DAROSTEP: Evaluating Step Counts as a Biomarker and Its Relationship on Treatment Outcomes in Vulnerable Patients With Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy

This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of safety in vulnerable adults who screen positive by a brief geriatric assessment (GA) and metastatic hormone-sensitive prostate cancer.

开始日期2025-11-01

申办/合作机构

The University of Chicago

NCT07016399

/ Not yet recruiting临床2期IIT

A Phase II Neoadjuvant Clinical Trial of the Androgen Receptor Inhibitor Darolutamide in Early-Stage Androgen Receptor Positive (AR+) Triple-Negative Breast Cancer

This phase II trial compares the effect of adding darolutamide to standard therapy versus standard therapy alone before surgery for the treatment of patients with stage II-IIIA androgen receptor positive triple-negative breast carcinoma. Standard therapy before surgery for triple-negative breast cancer typically consists of a combination of chemotherapy and immunotherapy drugs. Chemotherapy drugs, such as carboplatin, paclitaxel, doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving darolutamide in combination with standard therapy before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

开始日期2025-09-01

申办/合作机构

The Vanderbilt-Ingram Cancer Center

[+1]

NCT07027124

/ Not yet recruiting临床2期IIT

Neoadjuvant ADT and Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in NCCN High-risk and Molecularly Stratified Prostate Cancer Patients

This is a single-arm, phase II study of neoadjuvant combination therapy of Androgen Deprivation Therapy (ADT), [Gonadotropin-Releasing Hormone (GnRH) agonist Leuprolide], androgen receptor (AR)-antagonist Darolutamide and Pembrolizumab in a stratified high-risk localized prostate cancer cohort, followed by adjuvant treatment with Pembrolizumab (12 cycles) post-radical prostatectomy (RP).
Patients with National Comprehensive Cancer Network (NCCN) high-risk non-metastatic prostate cancer (localized or locally advanced) (defined as Gleason ≥8, disease stage >=cT3a, or PSA l >20 ng/mL) will be risk-stratified at a biopsy using Decipher, a commercial standard-of-care diagnostic assay. Patients satisfying all three criteria of high-risk genomic characteristics listed below as per the Decipher grid results will be enrolled in the study:
1. Decipher Genomic classifier, GC>0.6
2. AR activity score/AR-output gene signature (ARoS)>11.0
3. High Luminal B score/ PAM50 subtype signature

开始日期2025-06-01

申办/合作机构

Icahn School of Medicine at Mount Sinai

[+2]

100 项与达罗他胺相关的临床结果

登录后查看更多信息

100 项与达罗他胺相关的转化医学

登录后查看更多信息

100 项与达罗他胺相关的专利（医药）

登录后查看更多信息

522

项与达罗他胺相关的文献（医药）

2025-08-01·European Urology Oncology

Outcomes for [¹⁷⁷Lu]Lu-PSMA-617 with and Without Concurrent Use of Androgen Receptor Pathway Inhibitors in Patients with Metastatic Castration-resistant Prostate Cancer.

Article

作者: Riaz, Irbaz B ; Scharf, Zachary ; Muniz, Miguel ; Andrews, Jack R ; Kwon, Eugene D ; Childs, Daniel S ; Bilgin, Gokce Belge ; Thorpe, Matthew P ; Tuba Kendi, A ; Koch, Regina M ; Kase, Adam M ; Sartor, Oliver ; Zarka, Jabra G ; Orme, Jacob J ; Heath, Elisabeth I ; Johnson, Geoffrey B

BACKGROUND AND OBJECTIVE:

Large clinical trials, including VISION, have established the safety of combining [¹⁷⁷Lu]Lu-PSMA-617 with an androgen receptor pathway inhibitor (ARPI). Most patients receiving [¹⁷⁷Lu]Lu-PSMA-617 in the real-world setting have already progressed on an ARPI. This study aimed to assess the efficacy of [¹⁷⁷Lu]Lu-PSMA-617 in patients with and without the concurrent use of an ARPI.

METHODS:

We analyzed data from the Mayo Clinic Rochester radiopharmaceutical database, focusing on patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed after prior exposure to an ARPI and started treatment with [¹⁷⁷Lu]Lu-PSMA-617 between March 2022 and March 2023. Patients receiving concurrent ARPIs (abiraterone, enzalutamide, apalutamide, or darolutamide) were identified. Baseline characteristics were compared using Mann-Whitney U test and chi-square test. Outcomes of interest included prostate-specific antigen (PSA) 50 response, median number of cycles, and overall survival (OS) from the start of [¹⁷⁷Lu]Lu-PSMA-617, analyzed using Kaplan-Meier estimates and multivariate Cox regression.

KEY FINDINGS AND LIMITATIONS:

Among 256 patients, 106 (41.4%) received an ARPI with [¹⁷⁷Lu]Lu-PSMA-617. Those receiving an ARPI had lower baseline PSA levels (3.4 vs 29.7 ng/ml, p < 0.001) and lower rates of bone (77.4% vs 87.4%, p = 0.035) and visceral (18.9% vs 34%, p = 0.008) metastases. While patients on ARPIs were more likely to complete all six cycles of [¹⁷⁷Lu]Lu-PSMA-617 (63.2% vs 48.7%, p < 0.001), PSA50 response rates were similar (49.1% vs 47.3%, p = 0.786). Median OS was longer with concurrent ARPI use (not reached vs 15.3 mo, p < 0.001), but this difference was not significant on a multivariate analysis (hazard ratio = 1.03 [95% confidence interval: 0.68-1.55], p = 0.891) after accounting for baseline differences in other prognostic variables. Limitations include its single-center, retrospective design and a lack of standardized radiographic response assessment.

CONCLUSIONS AND CLINICAL IMPLICATIONS:

Among men with mCRPC previously exposed to an ARPI, continuation of the ARPI with [¹⁷⁷Lu]Lu-PSMA-617 did not improve PSA50 response rates or OS after adjusting for cohort imbalances in known prognostic factors. Further post hoc analyses using large clinical trial data are needed.

2025-08-01·Clinical Genitourinary Cancer

Do Older Patients With Metastatic Hormone-Sensitive Prostate Cancer Benefit From Triplet or Doublet Therapy? A Network Meta-Analysis

Article

作者: Kishi, Noriko ; Alerasool, Parissa ; Tsao, Che-Kai ; Zhou, Susu

INTRODUCTION:

With the expanded approval of androgen receptor axis-targeted (ARAT) agents, clinicians now have more treatment options to offer patients with metastatic hormone-sensitive prostate cancer (mHSPC). Uncertainty remains as to whether older population could benefit similarly from these intensification treatment options.

PATIENTS AND METHODS:

A systematic database search was performed for randomized controlled trials (RCTs) evaluating the efficacy of androgen deprivation therapy (ADT) in combination with ARAT agents and/or docetaxel in older patients (aged ≥ 70 or 75 years) with mHSPC. The primary endpoint was overall survival (OS). Indirect comparisons of available treatment options were estimated using a random-effects network meta-analysis.

RESULTS:

A total of 11 RCTs were eligible. In comparison with ADT alone or ADT + docetaxel doublet, darolutamide + ADT + docetaxel showed a significant OS benefit, with hazard ratios (HRs) of 0.47 (95% confidence interval [CI]: 0.28-0.77) and 0.61 (95% CI, 0.40-0.93), respectively. However, another triplet (abiraterone + ADT + docetaxel) failed to demonstrate a statistically significant OS benefit, with HRs of 0.61 (95% CI, 0.37-1.02) and 0.80 (95% CI, 0.52-1.24), respectively. Triplet therapies comprising darolutamide and abiraterone ranked first and second, with P score of .90 and .67, respectively, followed by darolutamide + ADT (0.61), apalutamide + ADT (0.60), enzalutamide + ADT (0.56), ADT + docetaxel (0.40), abiraterone + ADT (0.20) and ADT alone (0.06). Furthermore, our data suggest an additional benefit from adding docetaxel as a component of doublet and triplet therapies for older men with mHSPC.

CONCLUSION:

In older patients with mHSPC, triplet therapy comprising darolutamide, ADT, and docetaxel demonstrated the most pronounced OS benefit and ranked highest among currently available treatment options. Further studies are needed to explore the specific toxicities associated with the triplet regimen in this population to better balance oncologic benefits with treatment-related toxicities when making treatment decision.

2025-07-04·ONCOLOGIST

Functional assessment in patients with castration-resistant prostate cancer treated with darolutamide: results from the DaroAcT study

Article

作者: George, Daniel J ; Verholen, Frank ; Beer, Tomasz M ; Shore, Neal D ; Srinivasan, Shankar ; Ortiz, Jorge ; Morgans, Alicia K ; Wefel, Jeffrey S ; Winters-Stone, Kerri

Abstract:

Background:

Androgen receptor inhibitors (ARIs) are approved for the treatment of advanced prostate cancer; however, some patients may experience symptoms and side effects that hinder their physical functioning. The Timed Up and Go (TUG) and Short Physical Performance Battery (SPPB) tests are used to assess physical functioning in older adults and are recommended assessments for patients with prostate cancer, despite lacking validation in this setting.

Methods:

DaroAct (NCT04157088) was an open-label, multicenter, phase 2b study designed to evaluate the effects of the ARI darolutamide (lead-in phase) and darolutamide vs enzalutamide (randomized phase) on physical functioning in men with castration-resistant prostate cancer (CRPC). Only the lead-in phase, in which participants received darolutamide 600 mg twice daily, was completed. The TUG and SPPB tests were used to assess physical functioning.

Results:

The lead-in phase enrolled 30 participants. During 24 weeks of treatment, 8 (32.0%) of 25 evaluable participants exhibited clinically meaningful worsening in TUG from baseline (primary endpoint). At the week 24 visit, 5 (21.7%) of 23 participants had worsening in TUG time, and 8 (33.3%) of 24 participants had worsening in SPPB score. Because only 48% of participants had the same outcome on the TUG and SPPB tests, the study was terminated without initiating the randomized comparison.

Conclusion:

Most participants showed no clinically meaningful worsening in physical functioning after 24 weeks of darolutamide treatment, but poor agreement between tests was observed. Tools to accurately and consistently measure the impact of ARIs on physical functioning in patients with CRPC are needed.

367

项与达罗他胺相关的新闻（医药）

2025-07-30

·GlobeNewswire-Health Care

Celcuity Inc. Announces Pricing of Concurrent Public Offerings of 2.750% Convertible Senior Notes Due 2031 and Common Stock and Pre-Funded Warrants

MINNEAPOLIS, July 30, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (the “Company”), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the pricing of its underwritten public offering of $175,000,000 aggregate principal amount of its 2.750% convertible senior notes due 2031 (the “Convertible Notes” and such offering, the “Convertible Notes Offering”), and its underwritten public offering of 1,836,842 of shares of its common stock (the “Common Stock”) at a public offering price of $38.00 per share and, in lieu of Common Stock to investors who so choose, pre-funded warrants to purchase up to 400,000 shares of Common Stock (the “Pre-Funded Warrants”) at a public offering price of $37.999 per Pre-Funded Warrant, which represents the per share public offering price of each share of Common Stock less the $0.001 per share exercise price of each Pre-Funded Warrant (such offering, the “Common Stock Offering”). The Company has granted the underwriters of the offerings a 30-day option to purchase up to an additional $26,250,000 aggregate principal amount of Convertible Notes, solely to cover over-allotments, if any, in the Convertible Notes Offering and a 30-day option to purchase up to an additional 335,526 shares of Common Stock at the public offering price less the underwriting discounts and commissions in the Common Stock Offering. The Convertible Notes will be general, unsecured, senior obligations of the Company. The Convertible Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on February 1, 2026, at a rate equal to 2.750% per year. The Convertible Notes will mature on August 1, 2031, unless earlier converted, redeemed or repurchased by the Company. At any time until the close of business on the scheduled trading day immediately before the maturity date, the Convertible Notes will be convertible at the option of the holders based on an initial conversion rate of 19.4932 shares of Common Stock per $1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $51.30 per share of Common Stock, representing a premium of approximately 35% above the public offering price per share of Common Stock in the Common Stock Offering. In connection with the closing of the Convertible Notes Offering, the Company will irrevocably elect to settle conversions, if any, of the Convertible Notes in shares of Common Stock together with cash in lieu of any fractional share, if applicable. The Convertible Notes Offering is expected to close on August 1, 2025, while the Common Stock Offering is expected to close on July 31, 2025, in each case, subject to satisfaction of customary closing conditions. The closing of neither the Convertible Notes Offering nor the Common Stock Offering is conditioned upon the closing of the other offering. The Company estimates that the net proceeds from the Convertible Notes Offering and the Common Stock Offering will be approximately $248.7 million, after deducting underwriting discounts and commissions and the Company’s estimated offering expenses. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, which may include clinical trial expenditures, commercial launch expenditures, research and development expenditures, capital expenditures, expansion of business development activities and other general corporate purposes. If the underwriters exercise their over-allotment option, the Company expects to use any additional proceeds from the offering for the purposes described in the preceding sentence. In connection with the pricing of the Convertible Notes Offering, the Company has determined that it will not enter into the capped call transactions with one or more of the underwriters or affiliates thereof and/or other financial institutions (the “option counterparties”) as initially contemplated and as disclosed in the preliminary prospectus supplement relating to the Convertible Notes Offering and the preliminary prospectus supplement relating to the Common Stock Offering. As a result of the Company’s determination not to enter into the capped call transactions, certain investors in the Convertible Notes that were expecting to hedge their equity price risk through certain derivative transactions with the option counterparties may instead hedge their equity price risk after the pricing of the Convertible Notes Offering by entering into derivative transactions with other parties or selling shares of Common Stock, which could adversely affect the market price of our Common Stock and the Convertible Notes. Jefferies, TD Cowen and Leerink Partners are acting as joint book-running managers for the Convertible Notes Offering and the Common Stock Offering. LifeSci Capital is acting as lead manager for the Convertible Notes Offering and passive bookrunner for the Common Stock Offering. ICR Capital LLC is acting as financial advisor to the Company in connection with the Convertible Notes Offering. The Company has filed a registration statement (including a prospectus) with the Securities and Exchange Commission (the “SEC”) as well as a preliminary prospectus supplement with respect to each of the offerings to which this communication relates. Before you invest, you should read the applicable preliminary prospectus supplement and the prospectus in that registration statement and other documents the Company has filed with the SEC for more complete information about the Company and these offerings. You may obtain these documents by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, the Company, any underwriter or any dealer participating in the applicable offering will arrange to send you the applicable preliminary prospectus supplement (or, when available, the applicable final prospectus supplement) and the accompanying prospectus upon request to: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, or by telephone at (877) 821-7388, or by email at Prospectus Department@Jefferies.com; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at TD.ECM_Prospectus@tdsecurities; or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105 or by email at syndicate@leerink.com. This press release does not constitute an offer to sell or a solicitation of an offer to buy the Convertible Notes, any shares of Common Stock issuable upon conversion of the Convertible Notes, the shares of Common Stock, the Pre-Funded Warrants, any shares of Common Stock issuable upon the exercise of the Pre-Funded Warrants or any other securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration and qualification under the securities laws of such state or jurisdiction. ABOUT CELCUITY Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is currently enrolling patients. Celcuity is headquartered in Minneapolis. FORWARD-LOOKING STATEMENTS This press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the Convertible Notes Offering, the Common Stock Offering, our ability to complete such offerings on the anticipated timeline or at all and the anticipated use of the net proceeds therefrom, together with other statements that are not historical facts, are forward-looking statements that are estimates reflecting management’s best judgment based upon currently available information. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including our limited operating history; our potential inability to develop, validate and commercialize gedatolisib on a timely basis or at all; the uncertainties and costs associated with clinical studies and with developing and commercializing biopharmaceuticals; the complexity and difficulty of demonstrating the safety and sufficient magnitude of benefit to support regulatory approval of gedatolisib and other products we may develop; challenges we may face in developing and maintaining relationships with pharmaceutical company partners; the uncertainty and costs associated with clinical trials; the uncertainty regarding market acceptance by physicians, patients, third-party payors and others in the medical community, and with the size of market opportunities available to us; difficulties we may face in managing growth, such as hiring and retaining a qualified sales force and attracting and retaining key personnel; changes in government regulations; tightening credit markets and limitations on access to capital; stock market volatility or other factors that may affect our ability to access capital on favorable terms or at all; and obtaining and maintaining intellectual property protection for our technology and time and expense associated with defending third-party claims of intellectual property infringement, investigations or litigation threatened or initiated against us. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof. CONTACTS: Celcuity Inc.Brian Sullivan, bsullivan@celcuity.comVicky Hahne, vhahne@celcuity.com(763) 392-0123 ICR HealthcarePatti Bank, patti.bank@icrhealthcare.com(415) 513-1284

临床3期

2025-07-28

·PipelineReview

Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival (“PFS”) Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial

Hazard Ratios and Improvements in Median PFS are Unprecedented in HR+/HER2- Advanced Breast Cancer (“ABC”) MINNEAPOLIS, MN, USA I July 28, 2025 I Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. In the trial, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant (based on a hazard ratio [HR] of 0.24, 95% confidence interval [CI] 0.17-0.35; p<0.0001). The mPFS, as assessed by blinded independent central review (“BICR”), was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. The gedatolisib doublet also demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 67% compared to fulvestrant (HR of 0.33, 95% CI 0.24-0.48; p<0.0001). The mPFS, as assessed by BICR, was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months. The topline efficacy data from the VIKTORIA-1 PIK3CA wild-type cohort established several new milestones in the history of drug development for HR+/HER2- advanced breast cancer: Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial said: “Patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease has progressed while on, or after, treatment with a CDK4/6 inhibitor typically derive limited benefit from subsequent endocrine-based therapy. The topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing. To my knowledge, we have not seen Phase 3 results in patients with HR-positive, HER2-negative advanced breast cancer before where there was a quadrupling of the likelihood of survival without disease progression relative to the study control.” Treatment discontinuation due to a treatment-related adverse event for the gedatolisib triplet and gedatolisib doublet was lower than was observed in Arm D of the Phase 1b trial in patients with ABC, and lower than observed in any Phase 3 trials for currently approved drug combinations in HR+/HER2- ABC. Additionally, the gedatolisib triplet and gedatolisib doublet were better tolerated than was observed in the Phase 1b trial in patients with ABC, including lower rates of hyperglycemia and stomatitis. Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity said: “The topline data from VIKTORIA-1 demonstrate the potential for gedatolisib to become a transformative new medicine for the treatment of patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease progressed on or after treatment with CDK4/6 inhibitors. The 7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens are potentially paradigm shifting results. We are also very excited that treatment with gedatolisib combined with fulvestrant with or without palbociclib was well-tolerated by the VIKTORIA-1 patients and that only a few patients discontinued treatment due to an adverse event.” Brian Sullivan, Chairman, Chief Executive Officer and co-founder of Celcuity said, “The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population. We are excited about the potential opportunity to provide a breakthrough therapeutic option for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer.” Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year. Celcuity expects to submit a New Drug Application for gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025. Topline data for the VIKTORIA-1 PIK3CA mutation cohort is expected by the end of 2025. Webcast and Conference Call Information The Celcuity management team will host a webcast/conference call on Monday, July 28, 2025, at 8:00 a.m. ET to discuss the topline results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here , or register in advance for the teleconference here . A replay of the webcast will be available on the Celcuity website following the live event. Notes HR+/HER2- Breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 1 More than two million breast cancer cases were diagnosed globally in 2022. 1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis. 2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers. 2 Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer. 3 Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1. 4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. 8 Survival rates are low with 30% of patients anticipated to live beyond five years after diagnosis. 2 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research. VIKTORIA-1 VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is enrolling subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility criteria and do not have confirmed PI3KCA mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who meet eligibility criteria and have confirmed PI3KCA mutations (MT) are randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet. Gedatolisib Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway. 9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway. 11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA -mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data. 11,12 About Celcuity Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com . Follow us on LinkedIn and X . SOURCE: Celcuity

临床3期临床结果临床1期临床2期

2025-07-27

·ioncology

ESMO 2025丨59项中国泌尿肿瘤研究入选ESMO大会，一文畅览

点击蓝字，关注我们编者按：2025年欧洲肿瘤内科学会（ESMO）年会将于10月17日~21日在德国柏林召开。作为肿瘤学界的年度盛典，ESMO每年都会吸引上万名世界各地的肿瘤学大咖，为全球学者提供了良好的交流平台。目前公布的摘要标题中，入选的中国泌尿肿瘤研究数量再创新高，达到59篇，在此邀您共赏~口头报告摘要号：2592MO英文标题：Fruquintinib (FRUQ) plus sintilimab (SIN) versus axitinib (AXI) or everolimus (EVE) monotherapy as 2L treatment in pts with locally advanced or metastatic renal cell carcinoma (RCC)： results from phase 3 part of a randomized, open-label, active-controlled phase 2/3 study (FRUSICA-2)中文标题：呋喹替尼联合信迪利单抗对比阿昔替尼或依维莫司单药治疗局部晚期或转移性肾细胞癌患者的2L治疗：随机、开放标签、活性药物对照2/3期研究的3期部分结果（FRUSICA-2）讲者：叶定伟教授复旦大学附属肿瘤医院当地时间：Fri, 17.10.2025 16：00 - 17：30地点：Karlsruhe Auditorium - Hall 5.2摘要号：2598MO英文标题：The Intratumor Mycobiome Promotes Clear Cell Renal Cell Carcinoma Progression via Neutrophil-Mediated Immune Suppression中文标题：肿瘤内真菌群通过中性粒细胞介导的免疫抑制促进透明细胞肾细胞癌进展讲者：Kangli Ma 中国上海当地时间：Sun, 19.10.2025 08:30 - 10:00地点：Bonn Auditorium - Hall 7.1c摘要号：3071MO英文标题：Disitamab Vedotin plus Tislelizumab as Nephron-Sparing Therapy for High-Risk Upper Tract Urothelial Carcinoma： The Phase II DISTINCT-I Trial中文标题：维迪西妥单抗联合替雷利珠单抗作为高危上尿路尿路上皮癌的肾单位保留疗法：II 期 DISTINCT-I 临床试验讲者：黄吉炜教授上海交通大学医学院附属仁济医院当地时间：Sun, 19.10.2025 08:30 - 10:00地点：Bonn Auditorium - Hall 7.1c前列腺癌及阴茎癌壁报摘要号：1055P英文标题：Neoadjuvant and/or adjuvant immune checkpoint inhibitors combined with chemotherapy for locally advanced resectable penile squamous cell carcinoma中文标题：新辅助和/或辅助免疫检查点抑制剂联合化疗治疗局部晚期可切除阴茎鳞状细胞癌讲者：Zhao Zhigang 中国天津摘要号：2431P英文标题：The impact of lead-in androgen-deprivation therapy (ADT) on severe neutropenia (grade≥3) caused by docetaxel in patients with metastatic, hormone-sensitive prostate cancer(mHSPC)： A Post Hoc Analysis of ARASENS中文标题：转移性激素敏感前列腺癌（mHSPC）患者引入雄激素剥夺疗法（ADT）对多西他赛所致重度中性粒细胞减少症（≥3级）的影响：ARASENS的事后分析讲者：Yufan Y. Zhao 中国上海摘要号：2434P英文标题：The efficacy of rezvilutamide (Rez) plus androgen-deprivation therapy (ADT) in patients (pts) with high-volume, nonvisceral metastatic hormone-sensitive prostate cancer (HSPC)： a post hoc analysis of CHART study中文标题：瑞维鲁胺联合雄激素剥夺疗法（ADT）对高容量非内脏转移性激素敏感性前列腺癌（HSPC）患者的疗效：CHART研究的事后分析讲者：戴波教授复旦大学附属肿瘤医院摘要号：2435P英文标题：Predictive value of HSD3B1 germline single nucleotide polymorphism rs1047303 for hormone therapy outcomes in Chinese prostate cancer patients中文标题：HSD3B1种系单核苷酸多态性rs1047303对中国前列腺癌患者激素治疗结局的预测价值讲者：Ruofan Shi 中国上海摘要号：2436P英文标题：Efficacy and Safety of All-Site Radiation Therapy and Standard of Care Therapy with or without Docetaxel for Hormone-Sensitive High Gleason Score Prostate Cancer： 6-Year Results from a Long-Term Study中文标题：全部位放射治疗和标准治疗联合或不联合多西他赛治疗高格里森评分的激素敏感性前列腺癌的疗效和安全性：一项长期研究的6年结果讲者：Huizhu Chen 中国北京摘要号：2439P英文标题：Two-year Outcomes in Very High-Risk Localized Prostate Cancer Following Neoadjuvant Therapy with Poly(ADP-ribose) Polymerase Inhibitors and Abiraterone： A Pooled Post-Hoc Analysis of Two Prospective Trials中文标题：极高危局限性前列腺癌患者接受PARP抑制剂联合阿比特龙新辅助治疗后的两年疗效：两项前瞻性试验的汇总事后分析讲者：Tingwei Zhang 中国上海摘要号：2449P英文标题：CHAMPION study (NCT05717582) ： a prospective study of maximal-cytoreductive therapies for patients with de novo metastatic hormone-sensitive prostate cancer who achieve oligopersistent metastases during systemic treatment with apalutamide plus androgen deprivation therapy中文标题：CHAMPION研究：一项针对在接受阿帕他胺联合雄激素剥夺疗法全身治疗期间出现寡持续性转移的原发转移性激素敏感性前列腺癌患者的最大细胞减灭疗法的前瞻性研究讲者：Jian Pan 中国上海摘要号：2450P英文标题：Phase 1 study of QLH12016, an androgen receptor (AR) PROTAC degrader in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC)： safety, tolerability, and antitumor activity中文标题：雄激素受体（AR）PROTAC降解剂QLH12016在转移性去势抵抗性前列腺癌（mCRPC）患者中开展的I期临床试验：安全性、耐受性和抗肿瘤活性讲者：张顺教授南京鼓楼医院摘要号：2453P英文标题：Rezvilutamide (REZ) in combination with androgen-deprivation therapy (ADT) for prostate cancer patients with biochemical recurrence (BCR) post radical prostatectomy (RP)： preliminary results from a phase 2 trial中文标题：瑞维鲁胺联合雄激素剥夺疗法（ADT）治疗根治性前列腺切除术（RP）后生化复发（BCR）的前列腺癌患者：一项2期临床试验的初步结果讲者：邱雪峰教授南京鼓楼医院摘要号：2454P英文标题：RAPID trial (NCT06251492)： Radiation and Adebrelimab in Metastatic Castration Resistant Prostate Cancer with Imaging-Measurable Disease中文标题：RAPID试验：放疗和阿得贝利单抗治疗伴影像学可测量病变的转移性去势抵抗性前列腺癌讲者：Yu Wei 中国上海摘要号：2456P英文标题：Olaparib Plus Abiraterone in HRR-Mutated Metastatic Hormone-Sensitive Prostate Cancer中文标题：奥拉帕利联合阿比特龙治疗HRR突变转移性激素敏感性前列腺癌讲者：庄君龙教授南京鼓楼医院摘要号：2466P英文标题：Sodium-glucose cotransporter 2 inhibitors use in prostate cancer patients undergoing hormone therapy： a sequential target trial emulation study中文标题：钠-葡萄糖协同转运蛋白2抑制剂在接受激素治疗的前列腺癌患者中的应用：序贯靶向试验模拟研究讲者：Ruofan Shi 中国香港摘要号：2476P英文标题：Neoadjuvant darolutamide plus ADT for High/Very-high risk locally advanced PCa： a multi-center, open label, single arm, phase 2 trial中文标题：达罗他胺联合ADT新辅助治疗高危/极高危局部晚期前列腺癌：一项多中心、开放标签、单组、2期临床试验讲者：Kaiwei Yang 中国北京摘要号：2480P英文标题：A Randomized Controlled Clinical Trial on Autologous Vas Deferens Sling Suspension of the Vesicourethral Anastomosis to Improve Early Urinary Control After Retzius-sparing Robotic-assisted Radical Prostatectomy中文标题：自体输精管悬吊带悬吊膀胱尿道吻合口改善保留Retzius的机器人辅助根治性前列腺切除术后早期排尿控制的随机对照临床试验讲者：ZhiYuan Yang 中国南京摘要号：2481P英文标题：Pathological and Clinical Characteristics of Prostate Biopsy Cases with PSA Levels Below 4.0 ng/mL： A Multicenter Retrospective Real-World Study (YHCG-003 Study)中文标题：PSA水平低于4.0 ng/mL的前列腺穿刺活检病例的病理和临床特征：一项多中心回顾性真实世界研究（YHCG-003研究）讲者：苏瑞教授宁波大学附属第一医院摘要号：2482P英文标题：The Role of Sustained Serum Sodium Levels in Prognostication of Metastatic Prostate Cancer： Findings from Global Phase III Trials中文标题：血清钠水平持续在转移性前列腺癌预后中的作用：来自全球III期临床试验的结果讲者：倪旭栋教授复旦大学附属肿瘤医院摘要号：2486P英文标题：Quality of Life Analysis in Patients with High-Risk Localized Prostate Cancer Receiving Neoadjuvant Pamiparib plus Abiraterone and ADT： A Prospective Study中文标题：接受帕米帕利联合阿比特龙及ADT新辅助治疗的高危局限性前列腺癌患者生活质量分析：一项前瞻性研究讲者：Tangtao Gong 中国南京摘要号：2487P英文标题：Clinical Management Strategies and Long-Term Outcomes in Patients with Atypical Small Acinar Proliferation Diagnosed via Prostate Biopsy： A Collaborative Multicenter Real-World Study by Urologists and Pathologists (YHCG-002 Study)中文标题：前列腺穿刺活检确诊为非典型小腺泡增生患者的临床管理策略及长期疗效：一项泌尿科医生与病理科医生合作开展的多中心真实世界研究（YHCG-002研究）讲者：马琪教授宁波大学附属第一医院摘要号：2494P英文标题：Interim Analysis of a Prospective, Non-Randomized Controlled Study： Comparison of the Efficacy and Safety of ADT + Docetaxel vs. ADT + Novel Hormone Therapy in High Gleason Score Non-Metastatic Prostate Cancer Patients Receiving Radiotherapy中文标题：前瞻性、非随机对照研究的中期分析：ADT+多西他赛对比ADT+新型激素疗法在接受放射治疗的高Gleason评分非转移性前列腺癌患者中的疗效和安全性比较讲者：Mingwei Ma 中国北京摘要号：2523eP英文标题：Preclinical pharmacokinetic and pharmacodynamic study of GS24-B039, a 3-month long-acting abiraterone prodrug中文标题：疗效长达3个月的阿比特龙药物前体GS24-B039的临床前药代动力学和药效学研究讲者：Yujie Zhang 中国成都摘要号：2527eP英文标题：Baseline 68Ga-PSMA PET-CT for treatment monitoring of neoadjuvant prostate cancer： a diagnostic evaluation中文标题：用于前列腺癌新辅助治监测的68Ga-PSMA PET-CT基线：诊断评估讲者：Qing Zhang 中国南京摘要号：2530eP英文标题：HER2 Expression Dynamics and Prognostic Value in matched Hormone-Sensitive and Castration-Resistant Prostate Cancer Lesions中文标题：HER2在匹配的激素敏感性和去势抵抗性前列腺癌病变中的表达动态和预后价值讲者：Yelin Mulati 中国北京尿路上皮癌壁报摘要号：3075P英文标题： Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Guide Adjuvant Therapy in Locally Advanced Upper Tract Urothelial Carcinoma (CURATE-UTUC)： A Multicenter Prospective Longitudinal Cohort Study中文标题：循环和尿液肿瘤DNA动态预测局部晚期上尿路尿路上皮癌的微小残留病灶并指导辅助治疗（CURATE-UTUC）：一项多中心前瞻性纵向队列研究讲者：黄吉炜教授上海交通大学医学院附属仁济医院摘要号：3076P英文标题： Final results of a multi-center phase Ib/II study of RC48-ADC combined with tislelizumab as neoadjuvant treatment in patients with HER2 positive locally advanced muscle-invasive urothelial bladder cancer（Hope-03）中文标题：RC48-ADC联合替雷利珠单抗治疗HER2阳性局部晚期肌层浸润性膀胱癌患者的多中心Ib/II期临床研究最终结果（Hope-03）讲者：Feng Wen 中国成都摘要号：3079P英文标题： Efficacy and safety results from Formula-01： a phrase II study of Disitamab Vedotin plus BCG in HER2 high expression high-risk non-muscle invasive bladder cancer patients (HR-NMIBC)中文标题：Formula-01的疗效和安全性结果：维迪西妥单抗联合BCG治疗HER2高表达高危非肌层浸润性膀胱癌患者（HR-NMIBC）的II期临床讲者：Xingliang Tan 中国广州摘要号：3085P英文标题： PUNCH02： Interim results from a phase II study of tislelizumab combined with disitamab vedotin as a bladder preservation therapy for urine tumor DNA (utDNA)-defined clinical complete response (cCR) MIBC patients中文标题：PUNCH02：替雷利珠单抗联合维迪西妥单抗用于治疗尿液肿瘤DNA（utDNA）定义的临床完全缓解（cCR）MIBC患者的膀胱保留疗法的II期临床中期结果讲者：Bin Huang 中国成都摘要号：3086P英文标题： A Phase 2 Study of Organ-Preserving Therapy and Liquid Biopsy-Based Response Monitoring in Locally Advanced Muscle-Invasive Bladder Cancer中文标题：局部晚期肌层浸润性膀胱癌器官保留治疗及基于液体活检疗效监测的II期研究讲者：Jiani Deng 中国成都摘要号：3097P英文标题： Build an Artificial Intelligence Prediction Model Based on Deep Learning Technology to Predict the Muscular Invasion of Urothelial Carcinoma Preoperatively中文标题：基于深度学习技术构建人工智能预测模型，术前预测尿路上皮癌肌层浸润情况讲者：Sheng Xie 中国南充摘要号：3098P英文标题： Fibroblast Growth Factor Receptor 3 (FGFR3) - Driven Genomic Landscape and the Impact on Clinical Outcomes of Fexagratinib (Fexa) in Chinese metastatic or unresectable Urothelial Carcinoma (mUC)中文标题：成纤维细胞生长因子受体3（FGFR3）-驱动的基因组特征以及Fexagratinib对中国转移性或不可切除尿路上皮癌（mUC）临床结局的影响讲者：叶定伟教授复旦大学附属肿瘤医院摘要号：3099P英文标题： Proteogenomic characterization of the non-muscle-invasive bladder cancer response to BCG reveals potential therapeutic strategies中文标题：非肌层浸润性膀胱癌对BCG反应的蛋白质组学表征揭示了潜在的治疗策略讲者：Maoping Cai 中国上海摘要号：3103P英文标题： Chemotherapy plus Toripalimab as Neoadjuvant Therapy for Locally Advanced Upper Tract Urothelial Carcinoma： Mid-term Results from the Phase II, Multi-center Study (WUTSUP-01)中文标题：化疗联合特瑞普利单抗作为局部晚期上尿路尿路上皮癌的新辅助治疗：II期多中心临床研究（WUTSUP-01）的中期结果讲者：Kai Chen 中国成都摘要号：3110eP英文标题： Cost-Effectiveness of ctDNA-Guided Atezolizumab Adjuvant Therapy for High-Risk Muscle-Invasive Urothelial Carcinoma中文标题：ctDNA指导下的阿替利珠单抗辅助治疗高危肌层浸润性尿路上皮癌的成本效益讲者：Zihan Xue 中国天津摘要号：3114eP英文标题： Changes in Circulating Tumor Cells (CTCs) and HER-2 Expression as Indicators of Efficacy and Recurrence Prediction in Neoadjuvant Disitamab Vedotin (DV) Plus Toripalimab Treatment for Muscle-Invasive Bladder Cancer (MIBC)： Updated Data and Preliminary Outcomes for Recurrence中文标题：循环肿瘤细胞（CTC）及HER-2表达变化作为新辅助维迪西妥单抗联合特瑞普利单抗治疗肌层浸润性膀胱癌（MIBC）疗效及复发预测指标：最新数据及复发初步结果讲者：Yudong Cao 中国北京摘要号：3125eP英文标题： Kidney-Sparing Approach for Selected Localized High-Risk Upper Tract Urothelial Carcinoma： A Pilot Study Combining Endoscopic Thulium Laser Ablation with Perioperative Disitamab Vedotin and Immune Checkpoint Inhibitors中文标题：选择性局限性高危上尿路尿路上皮癌的肾脏保留疗法：内镜铥激光消融术联合围手术期维迪西妥单抗及免疫检查点抑制剂的初步研究讲者：Qihao Wang 中国成都摘要号：3127eP英文标题： Bulumtatug Fuvedotin (BFv 9MW2821), a novel Nectin-4 antibody-drug conjugate(ADC), combined with Toripalimab in patients with locally advanced or metastatic urothelial carcinoma(la/mUC)： Follow-up results from a phase 1b/2 study.中文标题：Bulumtatug Fuvedotin（BFv 9MW2821），一种新型Nectin-4抗体偶联药物（ADC），与特瑞普利单抗联合治疗局部晚期或转移性尿路上皮癌（la/mUC）患者：1b/2期研究的后续结果讲者：Shusuan Jiang 中国长沙肾癌壁报摘要号：2602P英文标题：Safety and efficacy of iparomlimab and tuvonralimab (QL1706) plus lenvatinib in previously untreated patients with clear cell renal cell carcinoma： results from a phase 1b study中文标题：艾帕洛利托沃瑞利单抗（QL1706）联合仑伐替尼治疗未经治疗的透明细胞肾细胞癌患者的安全性和有效性：一项1b期研究的结果讲者：董培中山大学肿瘤防治中心摘要号：2608P英文标题：Early detection of renal cell carcinoma： A novel cfDNA fragmentomics-based liquid biopsy assay.中文标题：肾细胞癌的早期检测：一种基于cfDNA片段组学的新型液体活检检测方法讲者：彭毓璐教授中山大学肿瘤防治中心摘要号：2615P英文标题：Belzutifan Plus Lenvatinib For Chinese Participants (pts) With Previously Treated Advanced Clear Cell Renal Cell Carcinoma (ccRCC)： Updated Results of Cohort 1 of the LITESPARK-010 Study中文标题：贝组替凡联合仑伐替尼治疗既往接受过治疗的晚期透明细胞肾细胞癌（ccRCC）中国患者：LITESPARK-010研究队列1更新结果讲者：盛锡楠教授北京大学肿瘤医院摘要号：2621P英文标题：Efficacy and safety of adjuvant penpulimab in very high-risk clear cell renal cell carcinoma： a prospective, controlled, phase II study中文标题：派安普利单抗辅助治疗极高危透明细胞肾细胞癌的疗效和安全性：一项前瞻性、对照、II期研究讲者：顾良友教授中国人民解放军总医院摘要号：2623P英文标题：CLEAR-IT： Preliminary Results from a Phase II Study Evaluating Cadonilimab Plus Lenvatinib in Previously Immunotherapy-Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)中文标题：CLEAR-IT：卡度尼利单抗联合仑伐替尼治疗既往接受过免疫疗法治疗的晚期/转移性透明细胞肾细胞癌（ccRCC）的II期临床研究的初步结果讲者：黄吉炜教授上海交通大学医学院附属仁济医院摘要号：2630P英文标题：Single-Nucleus Atlas of Collecting Duct Carcinoma Reveals Cellular Heterogeneity, Malignant Evolution, and Immunosuppressive Microenvironment中文标题：集合管癌单核图谱揭示细胞异质性、恶性演化和免疫抑制微环境讲者：Linhui Zhang 中国上海摘要号：2634P英文标题：Remodeling of the tumor microenvironment by PD-1 blockade plus tyrosine kinase inhibitor in advanced renal cell carcinoma中文标题：PD-1阻断联合酪氨酸激酶抑制剂对晚期肾细胞癌肿瘤微环境的重塑讲者：Qiyang Liang 中国北京摘要号：2638P英文标题：Anlotinib plus everolimus as first-line treatment for advanced non–clear cell renal cell carcinoma：1 year updated results from UC-001, a single-center, single-arm, phase II trial中文标题：安罗替尼联合依维莫司作为晚期非透明细胞肾细胞癌的一线治疗：单中心、单组、II 期临床试验UC-001的1年更新结果讲者：徐文浩教授复旦大学附属肿瘤医院摘要号：2640P英文标题：A multimodal multifaceted artificial intelligence model for diagnosing renal masses using contrast-enhanced computed tomography and laboratory parameters： A multicenter study中文标题：基于增强CT和实验室参数诊断肾脏肿块的多模态多方面人工智能模型：一项多中心研究讲者：Axide Haoni 中国上海摘要号：2642P英文标题：Immunosuppressive TREM2⁺ Tumor-Associated Macrophages Potentiate Immunotherapy Responsiveness in Patients with Clear Cell Renal Cell Carcinoma (ccRCC)中文标题：免疫抑制TREM2⁺肿瘤相关巨噬细胞增强透明细胞肾细胞癌（ccRCC）患者的免疫治疗反应讲者：Jiahao Wang 中国上海摘要号：2648P英文标题：Phase II Clinical Study of the Safety and Efficacy of Sintilimab in Combination with Axitinib and Stereotactic Radiotherapy in the Treatment of Local-regional Recurrent Renal Cell Carcinoma中文标题：信迪利单抗联合阿昔替尼及立体定向放射治疗治疗局部区域复发性肾细胞癌的安全性和有效性的II期临床研究讲者：Ruiqi Liu 中国广州摘要号：2653eP英文标题： Why Is TFE3 Prone to Breakage in TFE3-Rearranged Renal Cell Carcinoma? A Perspective on Non-Canonical DNA Structures and Their Stability中文标题：为什么TFE3在TFE3重排的肾细胞癌中容易断裂？非经典DNA结构及其稳定性的视角讲者：Xiaopo Zhang 中国南京摘要号：2654eP英文标题： Multi-Omic Analysis of Collecting Duct Carcinoma Reveals Enhanced Ribosome Biogenesis as a Driver of Malignant Metastasis and Proliferation中文标题：集合管癌的多组学分析揭示增强的核糖体生物合成是恶性转移和增殖的驱动因素讲者：Linhui Zhang 中国上海摘要号：2657eP英文标题： Deciphering Immune microenvironment landscape in renal cell carcinoma with different regimen：a single cell RNA sequencing study中文标题：解读不同治疗方案肾细胞癌的免疫微环境：单细胞RNA测序研究讲者：Jiahao Wang 中国上海摘要号：2660eP英文标题： Clinical Value of Dynamic ctDNA-MRD Monitoring in Advanced mRCC Patients Receiving TKIs Plus PD-1 Inhibitor Therapy中文标题：动态ctDNA-MRD监测在接受TKI联合PD-1抑制剂治疗的晚期mRCC患者中的临床价值讲者：黄吉炜教授上海交通大学医学院附属仁济医院摘要号：2661eP英文标题： Multi-omics Uncovers the Molecular Machinery Underlying Autophagic Regulation Leading to Metastasis in Chromophobe Renal Cell Carcinoma中文标题：多组学揭示导致嫌色性肾细胞癌转移的自噬调控的分子机制讲者：Jiayi Lu 中国上海摘要号：2670eP英文标题： SPP1+ Tumor-associated Macrophages Drive Immunotherapy Resistance via CD8+ T Cell Dysfunction in Clear Cell Renal Cell Carcinoma中文标题：SPP1+肿瘤相关巨噬细胞通过透明细胞肾细胞癌中的CD8+T细胞功能障碍驱动免疫治疗耐药性讲者：Wenbin Jiang 中国上海摘要号：2675eP英文标题： Shared Genetic and Proteomic Architecture Between Metabolic Syndrome and Renal Cell Carcinoma Highlights Insulin Resistance-CKD Axis中文标题：代谢综合征与肾细胞癌之间共享的遗传和蛋白质组学结构突出了胰岛素抵抗-CKD轴讲者：Chenhao Xu 中国成都摘要号：2676eP英文标题： Schwann Cell-Mediated Mechanisms in Renal Cell Carcinoma Metastasis at the Tumor Border Microenvironment中文标题：肾细胞癌在肿瘤边界微环境中转移的施万细胞介导机制讲者：Qiang Song 中国上海摘要号：2679eP英文标题：CT-based intratumoral vascular feature reveals a transcriptomic signature predictive of prognosis and treatment stratification in renal cell carcinoma中文标题：基于CT的肿瘤内血管特征揭示了可预测肾细胞癌预后和治疗分层的转录组特征讲者：Zilin Wang 中国成都相关研究信息来自ESMO官网。本文主要按照肿瘤类型和摘要号进行排序，如有遗漏和错误，欢迎留言~（来源：《肿瘤瞭望-泌尿时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床2期临床3期

100 项与达罗他胺相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11045	达罗他胺	L02BB06	DB12941

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
去势敏感前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2025-06-03
激素依赖性前列腺癌	欧盟	Bayer AG	2023-03-20
激素依赖性前列腺癌	冰岛	Bayer AG	2023-03-20
激素依赖性前列腺癌	列支敦士登	Bayer AG	2023-03-20
激素依赖性前列腺癌	挪威	Bayer AG	2023-03-20
转移性前列腺癌	日本	Bayer AG	2023-02-24
转移性去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2022-08-05
前列腺癌	巴西	Bayer AG	2020-01-01
去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2019-07-30

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
局限性前列腺癌	临床3期	法国	Bayer AG	2025-04-10
局限性前列腺癌	临床3期	马提尼克	Bayer AG	2025-04-10
复发性前列腺癌	临床3期	美国	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	中国	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	日本	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	澳大利亚	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	奥地利	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	比利时	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	巴西	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	加拿大	Bayer AG	2023-04-03

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03385655 (PC_BETS, ASCO2025)	临床2期	转移性去势抵抗性前列腺癌 AR mutation	72	Darolutamide 600mg od	醖鬱醖夢齋鹽糧餘衊鏇(蓋淵鹽餘鑰觸簾顧衊繭) = 11% 觸夢壓築襯糧網齋製鬱 (醖觸網構窪製廠醖衊繭 ) 更多	积极	2025-05-30
NCT05694819 (DISCOVARY, ASCO2025)	临床2期	AR阳性唾液腺肿瘤 androgen receptor (AR)-positive	33	Darolutamide	範壓夢鏇憲蓋觸鬱繭觸(觸壓蓋構蓋鹹繭衊網鬱) = 製廠鏇衊膚憲鏇網壓獵壓襯衊鬱簾憲網艱選遞 (憲製餘鹽選鹽憲積鏇夢 ) 更多	积极	2025-05-30
ASCO2025	N/A	激素依赖性前列腺癌	188	darolutamide (Non-metastatic hormone-sensitive prostate cancer (nmHSPC))	繭顧繭鏇鑰齋鑰窪鹽鑰(鑰醖鏇淵廠範繭淵廠夢) = Common side effects included fatigue 壓鑰顧窪襯鹹鹹廠夢憲 (鑰顧餘願簾蓋餘淵簾構 ) 更多	积极	2025-05-30
				darolutamide (Metastatic hormone-sensitive prostate cancer (mHSPC))
NCT04736199 (ARANOTE, ASCO2025)	临床3期	激素依赖性前列腺癌	-	Darolutamide 600 mg twice daily	鑰艱糧顧鏇壓壓糧衊製(遞壓鏇繭餘繭選衊範襯): HR = 0.72 (95% CI, 0.54 ~ 0.96) 更多	积极	2025-05-30
				Placebo
NCT03383679 (UCBG 3-06 START, Pubmed \| Lancet Oncol)	临床2期	晚期三阴性乳腺癌 AR positivity	94	Darolutamide 600 mg	獵網廠襯顧襯積窪積鹹(醖鬱構顧範鏇鏇選鹹醖) = toxicoderma (n=1) and headache (n=2) in the darolutamide group, and diarrhoea, general physical deterioration, and hepatic cytolysis in the capecitabine group (n=1 each) 鬱衊繭廠獵簾願糧範夢 (鹽蓋構窪鹹選範襯襯鬱 ) 更多	不佳	2025-03-01
				Capecitabine minimum 1000 mg/m2
NCT04558866 (ExBAT trial/LACOG 0620, ASCO_GU2025) 人工标引	临床2期	转移性去势抵抗性前列腺癌	48	testosterone cypionatetestosterone cypionate 400 mg on day 1, followed by oral darolutamide 1200 mg/day from day 29 to day 56, followed by a washout period of 7 days, in 63-day cyclesdarolutamide 1200 mg/day from day 29 to day 56, followed by a washout period of 7 days, in 63-day cycles	範壓製淵蓋築夢膚襯糧(獵繭構艱積鬱襯製鏇壓) = 鹹鬱夢鏇膚廠製鹹夢遞艱淵願鹽繭遞構醖獵淵 (獵遞鏇夢糧構範壓廠構, 26.3 ~ 55.0) 更多	积极	2025-02-13
NCT05526248 (ARAMON, ASCO_GU2025) 人工标引	临床2期	去势敏感前列腺癌	23	Darolutamide 600 mg twice daily	膚艱襯築餘夢鬱獵觸鑰(窪築鹽積鹹積顧築選糧) = 膚積願鹹壓蓋齋夢網鬱襯蓋壓憲選鑰製窪鹽壓 (遞襯糧膚襯繭積窪窪簾, 33 ~ 76) 更多	积极	2025-02-13
NCT04736199 (ARANOTE, ASCO_GU2025) 人工标引	临床3期	激素依赖性前列腺癌	669	DarolutamideDarolutamide 600 mg twice daily + ADT (High-volume disease)	簾願餘壓糧製衊遞鬱壓(構鹹鬱鹽鹽衊製繭顧蓋) = 鑰鬱蓋鹽壓齋齋壓簾觸願鏇糧觸範鹽鹹鹹膚觸 (窪築膚簾淵觸範壓選鬱 ) 更多	积极	2025-02-13
				DarolutamideDarolutamide 600 mg twice daily + ADT (low-volume disease)	簾願餘壓糧製衊遞鬱壓(構鹹鬱鹽鹽衊製繭顧蓋) = 顧顧選鹽艱壓醖獵齋艱願鏇糧觸範鹽鹹鹹膚觸 (窪築膚簾淵觸範壓選鬱 ) 更多
NCT06013475 (DEAR-EXT, ASCO_GU2025) 人工标引	N/A	去势抵抗性前列腺癌	1,205	DarolutamideDarolutamide (DARO) (Black pts)	-	积极	2025-02-13
				DarolutamideDarolutamide (DARO) (White pts)
NCT02799602 (ARASENS, ASCO_GU2025) 人工标引	临床3期	激素依赖性前列腺癌	1,305	Darolutamide + ADT + docetaxel (<75 y)	鏇製艱齋餘遞鏇壓夢鏇(顧構顧繭繭糧遞獵糧襯) = 獵繭繭範鏇糧積夢選網鹹廠鹹願窪糧獵餘觸淵 (構廠壓鏇淵構鹹願廠蓋 ) 更多	积极	2025-02-13
				Placebo + ADT + docetaxel (<75 y)	鏇製艱齋餘遞鏇壓夢鏇(顧構顧繭繭糧遞獵糧襯) = 觸鹹餘遞艱顧簾衊鏇簾鹹廠鹹願窪糧獵餘觸淵 (構廠壓鏇淵構鹹願廠蓋 ) 更多