A Prospective, Multicenter, Open-Label, Randomized, Comparative, Phase 4 Trial to Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea

The purpose of this study is to evaluate the efficacy and safety of lower dose calcineurin inhibitors (CNI) in combination with Everolimus in Korean heart transplant recipients.

开始日期2025-08-14

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

NCT06658093

/ Not yet recruiting早期临床1期IIT

RESTOR [Rapamycin and Everolimus Study Towards Older Rejuvenation]: An Exploratory PK/PD Study of mTOR Inhibition in Older Human Subjects

As people get older, there are changes in their cells and tissues that may affect their ability to function. This can lead to increased death and age-associated disorders, like heart disease, cancer, and Alzheimer's disease. Studies in animal models have been able to identify drugs that slow the aging process, leading to a longer, healthier life. This study is focused on one such family of drugs, called mTOR inhibitors, and the investigators' goal is to test two of these drugs, Rapamycin (Sirolimus) and Everolimus (Afinitor), in healthy older adults to find a dose and dose timing that can be used to safely inhibit mTOR to the levels seen in young healthy persons. The investigators expect that the dose that works well in women may differ from the one that is best in men, so it is important to include both sexes in this research.

开始日期2025-08-01

申办/合作机构

University of Texas Health Science Center At San Antonio

[+1]

NCT06972758

/ Not yet recruiting临床2期IIT

A Phase II Study of EVEerolimus as Adjuvant Therapy After Surgical Resection for Hepatocellular cArcinoma at High Risk of RecurreNCE [SEVERANCE Trial]

"Hepatic resection is the primary curative treatment for patients with a single, liver-confined hepatocellular carcinoma (HCC) without cirrhosis and is also considered in patients with cirrhosis if residual liver function is sufficient. Despite curative resection, HCC has a high recurrence rate, with 5-year recurrence reported in approximately 50-70% of patients. Notably, in cases with microvascular invasion, the 2-year recurrence rate reaches 55-75%. As early recurrence strongly impacts overall survival, there is a critical need for effective adjuvant therapies; however, no adjuvant treatment has yet been established or officially recommended.
Everolimus is an mTOR inhibitor that has both immunosuppressive and antitumor effects. Approximately half of HCC cases exhibit activation of the mTOR pathway. In liver transplant recipients, everolimus is used as an immunosuppressive agent and has been associated with reduced recurrence and improved survival, particularly in patients with elevated tumor markers prior to transplantation. Preclinical studies at our institution have shown that mTOR inhibitors may be more effective in preventing tumor development than in treating established tumors, suggesting a potential benefit for everolimus in an adjuvant setting.
To date, no clinical trials have assessed the efficacy of everolimus as adjuvant therapy after curative hepatic resection, especially in high-risk HCC characterized by microvascular invasion or satellite nodules. This study aims to evaluate the efficacy and safety of everolimus (Certirobell®) as adjuvant therapy in high-risk HCC patients following curative resection.
This is a single-center, single-arm Phase II trial conducted at Severance Hospital. A total of 60 patients with pathologically confirmed HCC who underwent R0 resection and exhibit high-risk features for recurrence will be enrolled. Everolimus will be administered orally, twice daily for 92 weeks, starting 4 to 6 weeks postoperatively. Initial dosing will be 1.0 mg twice daily, adjusted to 0.75 mg for patients with a Child-Pugh score of 6. Dosage adjustments will be made based on everolimus trough levels, targeting 3-8 ng/mL. Treatment will be discontinued upon confirmation of HCC recurrence.
The primary endpoint is 2-year recurrence-free survival (RFS). Secondary endpoints include 1-year RFS, 2-year recurrence rate, overall survival (OS), time to recurrence, and safety outcomes.
An interim analysis will be conducted after the first 30 patients have been enrolled and followed for 2 years. Based on the interim assessment of efficacy or futility, the study will either be terminated early or proceed with enrollment of an additional 30 patients.

开始日期2025-07-01

申办/合作机构

Yonsei University

100 项与依维莫司相关的临床结果

登录后查看更多信息

100 项与依维莫司相关的转化医学

登录后查看更多信息

100 项与依维莫司相关的专利（医药）

登录后查看更多信息

8,559

项与依维莫司相关的文献（医药）

2025-12-01·IMMUNOLOGIC RESEARCH

RAD001-mediated mTOR targeting in human monocyte-derived dendritic cells shifts them toward an immunogenic phenotype

Article

作者: Masoumi, Javad ; Hatami-Sadr, Amirhossein ; Baradaran, Behzad ; Hemmat, Nima ; Alipour, Shiva ; Alizadeh, Nazila ; Vaysi, Edris ; Naseri, Bahar

Dendritic cells (DCs) are essential for promoting T lymphocyte responses since they are specialist antigen-presenting cells. In order to maintain tolerance or initiate immune responses, DCs must be activated in a balanced and regulated manner via diverse signaling pathways. By using a variety of pharmacological components, we can interfere with their different signaling pathways such as the mammalian target of rapamycin (mTOR) to appropriately modulate DC activity. In the current study, we administered RAD001 to DCs to examine the impact of mTOR inhibition on both the maturation stage and the expression of inflammatory and anti-inflammatory molecules in DCs. Pure monocytes were cultivated and stimulated with GM-CSF and IL-4 to generate immature DCs, which were then treated with RAD001. The phenotype of the DCs was determined by labeling surface markers and analyzing them using flow cytometry. Afterward, real-time PCR was carried out to evaluate the expression of inflammatory and anti-inflammatory genes. The administration of RAD001 to DCs led to a significant upregulation in the gene expression of inflammatory molecules such as IL-12, IL-1β, tumor necrosis factor (TNF)-α, and nuclear factor kappa-light-chain-enhancer of activated B cells (NF-KB). Conversely, RAD001 treatment resulted in a decrease in the gene expression of anti-inflammatory factors IL-10 and indoleamine 2,3-dioxygenase (IDO). However, the expression of differentiation and antigen presentation-related markers CD11c and human leukocyte antigens (HLA)-DR in RAD001-treated DCs was lower and higher compared to the control group that did not receive the treatment, respectively. Taken together, our findings indicated that RAD001 treatment of DCs can be a promising therapeutic approach for the generation of immunogenic DCs in order to barricade tumor growth. However, there is a need for further investigation to evaluate the impacts of mTOR inhibition by RAD001 in DCs on cellular immune responses in vitro and in vivo.

2025-08-01·CELLULAR SIGNALLING

MTDH∆7-mediated mTOR activation drives doxorubicin resistance in triple-negative breast cancer: Relevance of mTORC1 inhibition on chemosensitization

Article

作者: Kotamraju, Srigiridhar ; Neeli, Praveen Kumar ; Pulipaka, Sriravali ; Kumari, Sunita ; Chandra, Yogesh ; Sahoo, Shashikanta ; Annamaneni, Sandhya ; Kuncha, Madhusudana

Cancer chemoresistance poses a major hurdle in the management of several cancers, including breast cancer. Herein, we identified MTDH∆7, a splice variant of an oncogene, metadherin (MTDH), promotes doxorubicin (Dox)-induced chemoresistance in triple-negative breast cancer (TNBC) cells. Increased MTDH∆7 levels were positively correlated with the elevated levels of ABC transporters like ABCB1, ABCC1, and ABCG2, which in turn caused reduced intracellular Dox accumulation. Interestingly, everolimus, an mTORC1 inhibitor, potentiated Dox-induced cytotoxicity by inhibiting MTDH∆7-mediated increase in the aforementioned ABC transporters. Moreover, MTDH∆7 overexpression increased mTORC1 levels, possibly due to MTDH∆7-induced accentuation of mitochondrial respiration, ATP production, and AMPK inactivation. Mechanistically, enhanced phosphorylation of mTORC1 caused NF-κB-dependent activation of cAMP-regulatory element-binding protein (CREB). Further, activated CREB led to an increase in the levels of ABCB1, ABCC1, and ABCG2. Inhibition of either mTORC1 by everolimus or NF-κB by BAY-11-7082 or CREB by H89 reversed these effects and mitigated MTDH∆7-mediated Dox efflux. Accordingly, while Dox administration alone marginally caused tumor regression in SCID mice bearing LV.MTDH∆7-MDA-MB-231 cells, administration of everolimus greatly sensitized these mice to Dox-induced tumor regression. In agreement, intriguingly, a positive correlation was observed between elevated MTDH∆7, mTORC1 activation, and ABC transporters level in human breast cancer patient cohort tumor samples. Collectively, MTDH∆7, by promoting mTOR signaling causes breast cancer chemoresistance, and that targeting MTDH∆7-mTOR signaling axis effectively enhances chemosensitization.

2025-07-01·PEDIATRIC NEUROLOGY

Long-Term Efficacy and Safety of Mammalian Target of Rapamycin Inhibitor Treatment for Subependymal Giant Cell Astrocytoma in Tuberous Sclerosis

Article

作者: Becker, Lena-Luise ; Ritter, David M ; Agricola, Karen ; Krueger, Darcy A ; Franz, David Neal ; Caré, Marguerite M

BACKGROUND:

Subependymal giant cell astrocytoma (SEGA) is a low-grade astrocytoma occurring in approximately 5%-20% of persons affected with tuberous sclerosis complex (TSC). Therapy options include surgical resection or medical treatment with mammalian target of rapamycin (mTOR) inhibitors ([mTORis] everolimus or sirolimus) to prevent further growth and neurosurgical interventions due to life-threatening hydrocephalus. Short-term follow-up of mTORi treatment has been described in earlier studies; however, data on long-term efficacy and safety are limited.

METHODS:

Patients from SEGA studies at Cincinnati Children's Hospital Medical Center with ongoing care at our center and consented to ongoing retrospective records collection were included in the study. Data was compiled from medical records.

RESULTS:

Our cohort consisted of 25 patients with TSC. All but one were currently receiving mTORi treatment with either sirolimus (N = 4, 20%) or everolimus (N = 20, 80%) at the time of evaluation. Median mTORi treatment duration was 15.5 years (range: 9.8-16.8 years, interquartile range: 0.9 years). One patient underwent SEGA resection after starting mTORi. None required cerebrospinal fluid diversion. In 19 patients (76%), SEGA was stable or decreased over time. In six patients, it increased slightly from pretreatment baseline. Ongoing adverse drug reactions (ADR) at their last visit were reported in the medical record of eight patients (33%) with intermittent aphthous ulcers being the most frequent (N = 7). Long-term ADRs were observed in 17 patients (68%), including hypercholesterolemia (N = 10), diabetes mellitus type 2 (N = 6), prediabetes (N = 1), hypertension (N = 6), and osteoporosis (N = 3).

CONCLUSIONS:

Long-term TSC-associated SEGA treatment with mTORi is safe, effective and well tolerated. Knowledge of adverse reactions is important for successful long-term therapy.

652

项与依维莫司相关的新闻（医药）

2025-05-31

·PipelineReview

HER3-DXd shows promising results in the phase II TUXEDO-3 study for patients with limited therapeutic options

CHICAGO, IL, USA I May 30, 2025 I Leading international medical research company, MEDSIR announced today the positive results of the TUXEDO-3 trial at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. This phase II study funded by Daiichi Sankyo and Merck, known as MSD outside of the United States and Canada, evaluates the efficacy and safety of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases and leptomeningeal disease, serious complications associated with advanced stages of the cancer. The study was carried out to evaluate HER3-DXd in patients with metastatic breast cancer (mBC) and advanced non-small cell lung cancer (aNSCLC) with active brain metastases, and patients with leptomeningeal disease from solid tumors. This is an antibody-drug conjugate to target HER3, a protein receptor found on the surface of cancer cells in brain metastases. HER3-DXd is an investigational agent consisting of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC Technology payload causes tumor DNA damage, killing cancer cells within and surrounding the tumor microenvironment The study showed promising results, which were presented today in an oral session. Results from the leptomeningeal cohort have been simultaneously published in the renowned journal Nature Medicine due to its potential benefit in patients with a high unmet medical need. In patients with breast cancer and brain metastases, intracranial responses were observed across all breast cancer subtypes, including luminal, HER2-positive, and triple-negative. Furthermore, some patients with breast cancer who had previously received antibody-drug conjugates also responded to HER3-DXd, highlighting the potential of HER3-DXd to overcome resistance and expand treatment options in refractory disease. Intracranial activity was also observed in patients with aNSCLC and brain metastases, intracranial responses were observed in patients whose tumors contained no activating driver mutations as well as patients whose tumors contained an EGFR or KRAS mutation. Overall, the data suggest that HER3-DXd may offer a novel treatment option for patients with secondary CNS involvement. KEY HIGHLIGHTS OF THE TUXEDO-3 STUDY The TUXEDO-3 study aimed to assess whether HER3-DXd could be an effective treatment option for patients with mBC and aNSCLC with active brain metastases, and leptomeningeal disease from solid tumors. The study met its primary objectives, with 23.8% and 30% patients achieving intracranial responses in active brain metastases from patients with mBC and aNSCLC, respectively, and 65% patients with leptomeningeal disease alive after 3 months. Side effects were consistent with previous studies using HER3-DXd. Tests evaluating quality of life and neurocognitive functions showed that patients remained stable or improved during the treatment follow-up. The primary objectives consisted of assessing the intracranial objective response rate in patients with active brain metastases from mBC and aNSCLC, and determining the number of patients with leptomeningeal disease alive after 3 months of starting the treatment. A NEW HOPE FOR DIFFICULT-TO-TREAT METASTASES “This study represents a significant advancement in our understanding of how to treat brain metastases and leptomeningeal disease, and we are hopeful that our findings will pave the way for new, effective therapies for these patients,” stated Dr. Matthias Preusser, MD, Medical Oncologist and Head of the Clinical Division of Oncology, Medical University of Vienna and Principal Investigator of TUXEDO-3. Dr. Rupert Bartsch, MD, PhD, Consultant Hematology and Medical Oncology, Medical University of Vienna, added: “Brain metastases and leptomeningeal disease represent severe complications in cancer, leading to increased morbidity and mortality, and HER3-DXd could be a promising therapeutic alternative for these patients.” ABOUT UMMET CANCER NEEDS Unmet cancer needs refer to gaps in resources, support, and treatment options that exist for cancer patients. Addressing unmet cancer needs is crucial to improving quality of life and outcomes for cancer patients. Through the collaborative work of healthcare providers, policymakers, and patient advocacy groups unmet cancer needs can be identified to help provide patients with comprehensive and quality care. SHOWCASING PROMISING COLLABORATIVE TRIALS AT ASCO In addition to the oral presentation of TUXEDO-3, MEDSIR will present both ADELA and WIN-B studies in poster format. The ADELA clinical trial is an ongoing international phase III study in collaboration with The Menarini Group, a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc., a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients. The study is being conducted across multiple countries which combines elacestrant with everolimus to treat advanced ER+/HER2- breast cancer with ESR1 mutations, aiming to delay disease progression. Regarding WIN-B , is a phase Ib/II, multi-center investigator-initiated trial, evaluating the safety and preliminary efficacy of combining Debiopharm’s selective WEE1 inhibitor, Debio 0123 and Gilead’s antibodydrug conjugate Trodelvy ® (sacituzumab govitecan-hziy) in advanced HR+/HER2- and triple-negative breast cancers. MEDSIR active presence at the ASCO Annual Meeting 2025 reinforces its leadership in excellence-driven oncology research and highlights its focus on addressing unmet needs in cancer treatment, with the aim of not leaving any patient left behind. ABOUT MEDSIR Established in 2012, MEDSIR prides itself on working closely with its strategic partners to drive innovation in oncology research. Operating in Spain and the United States, the company provides end-to-end clinical trial management, from study design to publication, with an extensive global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that enables research partners to benefit from the best of both worlds: industry clinical research and investigator-driven trials. With the aim of promoting independent research worldwide, MEDSIR has formed a strategic alliance with Oncoclínicas, the leading oncology group in Brazil, which offers outstanding research potential in South America. For further information: www.medsir.org SOURCE: MEDSIR

临床结果临床2期ASCO会议临床3期临床1期

2025-05-30

·生物制药小编

债务融资2.6亿美元，为核药上市做准备

近日，Isotope Technologies Munich公司（ITM）宣布与Blue Owl Capital达成了一项高达2.625亿美元的债务融资协议。据协议，ITM在交易完成后将立即获得一笔1.4亿美元的资金，并可根据需要获得额外批次资金。这笔融资将用以支持其核药ITM-11的商业化准备工作。推出治疗性核药ITM是一家老牌放射性同位素开发公司，成立于2004年。成立以来，公司也完成了多轮融资。在2024年公司就完成了两次融资，包括2024年6月由淡马锡领投的1.88亿欧元（约2.04亿美元）融资，以及2024年10月由弘晖基金主导的1.8亿欧元的上市前轮投资。最初，ITM主要致力于医用放射性同位素的研发、生产以及供应。2007年，其子公司ITM Medical Isotopes GmbH成立，公司开始开发诊疗性的放射性同位素产品。2016年和2018年，ITM分别推出了EndolucinBeta®和TOCscan®两款诊疗性放射性同位素产品。官网显示，ITM目前共有12条核药研发管线，涵盖Lu-177、Ga-68、Ac-225、Tb-161多种放射性同位素疗法。目前最快的管线ITM-11（n.c.a.177Lu-edotreotide），目前处于临床III期阶段，涉及的适应症包括胃肠胰神经内分泌肿瘤，副神经节瘤、嗜铬细胞瘤等。2025年3月，ITM在ENETS年会上公布了ITM-11治疗1/2级生长抑素受体（SSTR）阳性胃肠胰神经内分泌肿瘤（GEP-NETs）Ⅲ期临床COMPETE顶线数据。试验结果显示，与标准治疗（everolimus）相比，ITM-11显著延长了患者的无进展生存期（23.9 vs14.1），初步OS数据也展现初延长趋势。安全性方面，ITM-11治疗相关不良事件（TEAEs）发生率也低于对照组（82.5% vs 97.0%），且未出现意外的TEAEs。基于该数据，ITM计划在2025年向FDA提交新药上市申请（NDA），并准备商业化推广。2021年12月，远大医药还引进了ITM三款RDC(放射性核素偶联物)TOCscan（即ITM-14D）、ITM-11以及ITM-413在大中华区的独家开发、生产及商业化权益。据协议，ITM可获得不超过5.2亿欧元的授权许可及里程碑付款。放射性同位素供应商除了拥有丰富的核药管线之外，ITM在业内更值得一提的放射性同位素的生产能力。ITM是全球最大的医用放射性同位素生产企业之一，据公司称，其位于德国慕尼黑Neufahrn的NOVA工厂是全球最大的Lu-177生产基地，去年4月，公司宣布该工厂正式投入运营。目前，ITM也是多家核药公司的放射性同位素供应商，公司与Radiopharm Theranostics（供应Lu-177）、Ariceum Therapeutics（供应Ac-225）、Alpha-9 Oncology（供应Ac-225）、Telix Pharmaceuticals（供应Lu-177）、POINT Biopharma Global（供应Lu-177）、Y-mAbs Therapeutics（供应Lu-177）（等在内多家公司达成了供应协议。放射性同位素的生产也十分具有挑战性，其生产环节复杂、时效性要求极高，之前诺华和BMS都遇到生产问题，诺华的Pluvicto一度因产能不足，以至于暂停了新患者的招募工作。BMS也曾公开表示由于Ac-225的短缺，不得不暂停其RYZ101的Ⅲ期试验的新患者招募。另外，之前ITM就透露计划在中国上海成立子公司，这笔债务融资除了用以支持ITM-11的商业化准备工作之外，也将用于进一步扩展其全球业务，包括在中国上海成立子公司。参考出处https://www.itm-radiopharma.com/news/press-releases/press-releases-detail/itm-secures-up-to-262-5m-in-non-dilutive-debt-financing-with-blue-owl-managed-funds-727/https://www.itm-radiopharma.com/news/press-releases/press-releases-detail/itm-presents-positive-topline-phase-3-compete-trial-data-with-nca-177lu-edotreotide-itm-11-a-targeted-radiopharmaceutical-therapy-in-patients-with-grade-1-or-2-gastroenteropancreatic-neuroendocrine-tumors-at-the-enets-2025-conference-688/https://www.itm-radiopharma.com/news/press-releases/press-releases-detail/ITM_Announces_Operational_Readiness_for_NOVA_Facility,_the_Worlds_Largest_Lutetium-177_Production_Site-664/

临床3期放射疗法引进/卖出上市批准临床结果

2025-05-28

·EINPresswire

Olema Oncology Announces Palazestrant Dose Selection and Trial-in-Progress Poster at ASCO 2025 Annual Meeting

90 mg once-daily palazestrant dose selected for Part 2 of the Phase 3 OPERA-01 monotherapy trial and for the Phase 3 OPERA-02 combination trial with ribociclib OPERA-01 trial-in-progress poster to be presented on Monday, June 2 between 9:00am–12:00pm CT / 10:00am–1:00pm ET SAN FRANCISCO, May 28, 2025 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced it has aligned with the U.S. Food and Drug Administration (FDA) to select 90 mg of palazestrant as the dose for Part 2 of the ongoing registrational Phase 3 OPERA-01 trial in second- and third-line estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer. This update will be presented as part of the OPERA-01 trial-in-progress poster at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago, Illinois. The FDA also selected 90 mg of palazestrant in combination with the approved dose of CDK4/6 inhibitor ribociclib for the pivotal Phase 3 OPERA-02 trial in frontline ER+/HER2- metastatic breast cancer. “Metastatic breast cancer treatment continues to be challenged by resistance mechanisms resulting in a clear need for innovative new therapies. We believe the clinical results we have achieved to date for palazestrant across ESR1 mutant and wild-type ER+/HER2- tumors, both in the monotherapy and combination treatment settings, support palazestrant’s potential to have a significant positive impact on breast cancer patients,” said Naseem Zojwalla, M.D., Chief Medical Officer of Olema Oncology. “We remain steadfast in our commitment to these patients, and with 90 mg of palazestrant confirmed as the selected dose, we are focused on rapidly advancing our OPERA-01 and OPERA-02 pivotal trials with top-line data from OPERA-01 anticipated in 2026 and a potential commercial launch in 2027.” Poster Presentation Details Title: OPERA-01: A randomized, open-label, phase 3 study of palazestrant (OP-1250) monotherapy vs standard-of-care endocrine therapy for patients with ER+, HER2- advanced breast cancer after endocrine and CDK4/6 inhibitor therapy Abstract Number: TPS1131 Poster Number: 104b Poster Session: Breast Cancer – Metastatic Date/Time: June 2, 2025 from 9:00am–12:00pm CT / 10:00am–1:00pm ET Additional information can be found on the ASCO Annual Meeting website , including abstracts. A copy of the poster will be made available on the Publications page of Olema’s website in alignment with ASCO’s embargo policy. About Palazestrant (OP-1250) Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01. Learn more at www.opera01study.com . Palazestrant is also being evaluated in multiple Phase 1/2 trials in combination with ribociclib, palbociclib, alpelisib, and everolimus. It will also be evaluated in combination with ribociclib in the planned pivotal Phase 3 trial, OPERA-02. About Olema Oncology Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), currently in a Phase 3 clinical trial called OPERA-01. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical trial. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com . Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “may,” “potential,” “upcoming,” “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential of palazestrant to have a significant positive impact on breast cancer patients, the timing for initiation, enrollment, and results of Olema’s clinical trials, the timing of a potential commercial launch for palazestrant, and the potential beneficial characteristics, safety, tolerability, efficacy, and therapeutic effects of palazestrant. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and other filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Media and Investor Relations Contact Courtney O’Konek Vice President, Corporate Communications Olema Oncology media@olema.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床3期ASCO会议快速通道临床1期

100 项与依维莫司相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D02714	依维莫司	L04AA18 L01XE10	DB01590

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
癫痫	美国	Novartis Pharmaceuticals Corp.	2021-12-30
癫痫部分性发作	美国	Novartis Pharmaceuticals Corp.	2018-04-10
结节性硬化症相关的肾血管平滑肌脂肪瘤	中国	Novartis Pharma AG	2016-12-12
复发性乳腺癌	日本	Novartis Pharma AG	2014-03-17
胰神经内分泌瘤	中国	Novartis Pharma AG	2014-02-01
室管膜下巨细胞星形细胞瘤	中国	Novartis Pharma AG	2014-02-01
HR阳性/HER2阴性乳腺癌	美国	Novartis Pharmaceuticals Corp.	2012-07-20
胃肠胰神经内分泌肿瘤	日本	Novartis Pharma AG	2011-12-22
结节性硬化症	欧盟	Novartis Europharm Ltd.	2011-09-02
结节性硬化症	冰岛	Novartis Europharm Ltd.	2011-09-02
结节性硬化症	列支敦士登	Novartis Europharm Ltd.	2011-09-02
结节性硬化症	挪威	Novartis Europharm Ltd.	2011-09-02
星形细胞瘤	美国	Novartis Pharmaceuticals Corp.	2010-10-29
血管平滑肌脂肪瘤	加拿大	Novartis Pharmaceuticals Canada, Inc.	2010-03-15
HR阳性乳腺癌	欧盟	Novartis Europharm Ltd.	2009-08-02
HR阳性乳腺癌	冰岛	Novartis Europharm Ltd.	2009-08-02
HR阳性乳腺癌	列支敦士登	Novartis Europharm Ltd.	2009-08-02
HR阳性乳腺癌	挪威	Novartis Europharm Ltd.	2009-08-02
神经内分泌肿瘤	欧盟	Novartis Europharm Ltd.	2009-08-02
神经内分泌肿瘤	冰岛	Novartis Europharm Ltd.	2009-08-02

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
癫痫发作	临床3期	美国	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	日本	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	澳大利亚	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	比利时	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	加拿大	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	哥伦比亚	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	法国	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	匈牙利	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	意大利	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	墨西哥	Novartis Pharmaceuticals Canada, Inc.	2017-06-08

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


ESMO_ELCC2025	临床2期	胸腺上皮肿瘤二线	37	Everolimus	觸築製蓋網築壓鏇膚蓋(醖築鑰艱鏇膚鹹蓋壓願) = occurring in 8 (21.6%) pts 積鬱膚窪製遞構範鏇顧 (齋衊製鹽膚蓋選衊築糧 ) 更多	积极	2025-03-26
NCT03032406 (CTgov)	临床2期	复发性乳腺癌	53	hydroxychloroquine (HCQ Alone (Arm A))	憲繭積鬱鏇襯願鹽構鑰 = 鏇衊膚網蓋顧膚憲製蓋膚選膚蓋憲醖願鬱壓網 (網壓廠簾築夢選鹹廠顧, 壓鏇廠鏇獵鏇繭窪鏇艱 ~ 鬱淵醖積壓鏇網積網衊) 更多	-	2025-03-05
				everolimus (EVE Alone (Arm B))	憲繭積鬱鏇襯願鹽構鑰 = 餘獵廠選鑰鹹艱網鏇選膚選膚蓋憲醖願鬱壓網 (網壓廠簾築夢選鹹廠顧, 範壓壓淵衊築憲艱醖積 ~ 艱憲繭選壓壓製網範願) 更多
NCT02991807 (CTgov)	临床1/2期	PTEN 错构瘤综合征	46	RAD001 (RAD001)	壓遞蓋選膚襯鏇淵餘鹽 = 範網構範廠醖膚鹽壓夢構壓蓋膚鏇獵鬱鬱構夢 (糧廠壓顧構觸鏇鬱選餘, 醖簾遞餘顧選顧糧網醖 ~ 衊簾齋壓構膚廠壓糧餘) 更多	-	2025-02-17
				Placebo (Placebo)	壓遞蓋選膚襯鏇淵餘鹽 = 積廠憲鬱製艱網顧衊範構壓蓋膚鏇獵鬱鬱構夢 (糧廠壓顧構觸鏇鬱選餘, 觸網膚醖構齋糧憲艱蓋 ~ 繭願憲鹹鹽艱觸簾範餘) 更多
NCT02842749 (CTgov)	临床4期	胰腺神经内分泌肿瘤	61	Everolimus (Everolimus)	簾選廠繭觸齋鬱艱醖構 = 夢製醖願憲繭夢鹹衊簾簾遞觸膚鑰齋糧艱鹹觸 (壓鹹淵鏇願選膚齋選齋, 鹽憲鹽選艱繭廠鹽窪構 ~ 顧憲夢積遞餘餘窪積網) 更多	-	2025-02-10
				Everolimus (Everolimus-on Treatment)	壓積簾淵齋鬱範壓鏇憲(構願積範簾願獵願構獵) = 糧鹽構鑰簾鹽餘製鬱鬱選觸衊窪鑰壓獵獵襯窪 (積鬱壓鏇願鬱鏇鹽蓋願, 網網築鹹繭醖簾夢膚淵 ~ 鹽鹽廠鑰鹽網廠顧範鑰) 更多
NCT03070301 (CTgov)	临床2期	晚期神经内分泌肿瘤	21	LEE011+Everolimus	築築鏇衊築觸鑰齋艱鑰 = 範鏇窪鑰顧鏇壓範餘窪衊壓顧壓遞鏇襯製餘顧 (襯餘鏇糧齋齋選顧壓鑰, 艱齋壓獵鹽網鏇網構襯 ~ 蓋網窪網艱鹽構遞鏇鹹) 更多	-	2024-10-10
NCT01678664 (EVACEL \| FFCD 1104-EVACEL-GTE, CTgov)	临床2期	内分泌腺肿瘤 \| 肝转移 \| 神经内分泌肿瘤	74	embolization+Doxorubicin+Everolimus	廠壓鑰鏇鹽衊醖鬱網製(獵範醖顧構積鏇醖範積) = 鑰夢簾獵衊觸築衊顧鹽窪獵鑰壓鬱餘艱夢觸獵 (膚鹽鹽淵構鏇衊築醖憲, 壓鹽窪築選繭鹹顧艱鹽 ~ 齋齋觸鹹壓構襯構顧範) 更多	-	2024-09-25
EVERGREEN (ESMO2024)	N/A	ER阳性/HER2阴性乳腺癌 PIK3CA-AKT1-PTEN pathway alterations	207	Everolimus-based endocrine therapy (EVE)	觸窪構製範壓獵網築鹽(構蓋構艱糧鏇衊築鹽願) = 觸積製膚醖餘網繭蓋選餘鑰獵艱蓋齋積鹹遞選 (糧遞膚簾醖廠鏇構餘網 ) 更多	不佳	2024-09-16
				Endocrine therapy alone (ETa)	觸窪構製範壓獵網築鹽(構蓋構艱糧鏇衊築鹽願) = 衊遞鹹襯壓襯醖鹽廠製餘鑰獵艱蓋齋積鹹遞選 (糧遞膚簾醖廠鏇構餘網 ) 更多
ESMO2024	临床1期	晚期神经内分泌肿瘤	92	Everolimus 6.1 - 10mg	積夢觸衊廠網鹹築觸糧(鹹觸網築餘夢鬱夢簾蓋) = 積築壓醖選蓋窪範艱夢鏇衊鬱築廠構製範鬱艱 (艱壓艱觸糧簾獵襯願廠, 3.7 ~ 32) 更多	积极	2024-09-16
				Everolimus 6mg or less	積夢觸衊廠網鹹築觸糧(鹹觸網築餘夢鬱夢簾蓋) = 鬱壓蓋餘構壓醖蓋簾衊鏇衊鬱築廠構製範鬱艱 (艱壓艱觸糧簾獵襯願廠, 3.9 ~ 27) 更多
NCT02338609 (EXIST-LT, CTgov)	临床4期	-	15	Everolimus	獵繭艱選願齋顧憲蓋遞 = 簾網網鹹繭鹹夢繭蓋獵簾繭鏇衊鬱網網淵餘築 (窪艱鹽遞範醖鹽鬱獵憲, 製製遞鏇齋網選壓顧夢 ~ 餘醖憲糧窪積醖顧鏇繭) 更多	-	2024-08-09
NCT01120249 (EVEREST, Pubmed \| JAMA Netw Open) 人工标引	临床3期	肾细胞癌 \| 乳状状肾细胞癌辅助	110	Everolimus	壓鹽選鹽鑰積製遞鏇憲(製構顧範膚鹹鏇鑰範鑰) = 製憲齋遞積構壓鏇醖鹽憲鑰製齋憲蓋積鹽範鹹 (鑰製鹹憲構廠夢範憲衊 ) 更多	不佳	2024-08-01
				Placebo	壓鹽選鹽鑰積製遞鏇憲(製構顧範膚鹹鏇鑰範鑰) = 製製夢願鬱淵鏇餘築繭憲鑰製齋憲蓋積鹽範鹹 (鑰製鹹憲構廠夢範憲衊 ) 更多