An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, and a Substudy Evaluating PIKTOR With Paclitaxel Plus an Insulin-Suppressing Diet, in Patients With Advanced or Recurrent Endometrial Cancer

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer.

开始日期2024-12-12

申办/合作机构

Faeth Therapeutics, Inc.

NCT05300048

/ Active, not recruiting临床1期

A Phase 1b Study of Serabelisib in Combination with an Insulin Suppressing Diet (Study ISD) and with or Without Nab-paclitaxel in Adult Subjects with Advanced Solid Tumors with PIK3CA Mutations with or Without PTEN Loss

This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib (an investigational PI3K inhibitor) when combined with an ISD and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity.

开始日期2022-04-22

申办/合作机构

Faeth Therapeutics, Inc.

NCT04073680

/ Unknown status临床1/2期

A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors With PIK3CA or KRAS Mutations

This study aims to test the hypothesis that combining serabelisib, a PI3K alpha isoform inhibitor, with an SGLT2 inhibitor, canagliflozin will improve efficacy in the treatment of patients with advanced solid tumors.

开始日期2020-09-01

申办/合作机构

Petra Pharma Corp.

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100 项与色雷利塞相关的转化医学

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100 项与色雷利塞相关的专利（医药）

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项与色雷利塞相关的文献（医药）

2025-08-10·BRITISH JOURNAL OF CANCER

Multi-node inhibition targeting mTORC1, mTORC2 and PI3Kα potently inhibits the PI3K/AKT/mTOR pathway in endometrial and breast cancer models

Article

作者: Cantley, Lewis C ; Mukherjee, Siddhartha ; Goncalves, Marcus D ; Maddocks, Oliver D K ; Tyrakis, Petros A ; Kampjut, Domen ; Lindström, H Jonathan G ; Hopkins, Benjamin D ; Chirnomas, Deborah ; Steele, Georgina F

Abstract:

Background:

While PI3K/AKT/mTOR signalling plays a critical role in cancer, targeting this pathway with single node inhibitors has limited efficacy due to several known factors such as pathway feedback reactivation, co-occurring pathway mutations, and systemic glucose dysregulation leading to hyperinsulinemia. While multi-node inhibition approaches have shown promising clinical efficacy, they require further mechanistic characterisation.

Methods:

Using models of endometrial and breast cancer, we evaluated the efficacy of a multi-node PI3K/AKT/mTOR pathway inhibitor approach utilising the dual mTORC1/mTORC2 inhibitor sapanisertib, PI3Kα inhibitor serabelisib and an insulin-supressing diet. Pathway signalling inhibition versus a range of single-node inhibitors was measured via S6, AKT and 4E-BP1 phosphorylation.

Results:

The serabelisib-sapanisertib combination more effectively suppressed PI3K/AKT/mTOR pathway signalling, particularly 4E-BP1, than single-node inhibitors, including alpelisib, capivasertib, inavolisib, everolimus and mutant-specific PI3K inhibitors RLY-2608 and STX-478. Serabelisib plus sapanisertib combined effectively with a range of other therapeutics, such as chemotherapies, hormone targeted therapies and CDK4/6 inhibitors. In xenograft models, sapanisertib, serabelisib plus paclitaxel/insulin supressing diet achieved complete inhibition of tumour growth/tumour regression.

Conclusion:

Multi-node PI3K/AKT/mTOR pathway inhibition with serabelisib, sapanisertib and ISD is highly effective in preclinical models of endometrial and breast cancer, supporting continued clinical development in these and other solid tumours.

2025-08-01·MOLECULAR DIVERSITY

iDCNNPred: an interpretable deep learning model for virtual screening and identification of PI3Ka inhibitors against triple-negative breast cancer

Article

作者: Jaiswal, Ravishankar ; Siddiqi, Mohammad Imran ; Bhati, Girdhar ; Ahmed, Shakil

Triple-negative breast cancer (TNBC) lacks estrogen, progesterone, and HER2 expression, accounting for 15-20% of breast cancer cases. It is challenging due to low therapeutic response, heterogeneity, and aggressiveness. The PI3Ka isoform is a promising therapeutic target, often hyperactivated in TNBC, contributing to uncontrolled growth and cancer cell formation. We have proposed an interpretable deep convolutional neural network prediction (iDCNNPred) system using 2D molecular images to classify bioactivity and identify potential PI3Ka inhibitors. We built Custom-DCNN models and pre-trained models such as AlexNet, SqueezeNet, and VGG19 by using the Bayesian optimization algorithm, and found that our Custom-DCNN model performed better than a pre-trained model with lower complexity and memory usage. All top-performed models were screened with the Maybridge Chemical library to find predictive hit molecules. The screened molecules were further evaluated for protein-ligand interaction with molecular docking and finally 12 promising hits were shortlisted for biological validation using in-vitro PI3K inhibition studies. After biological evaluation, 4 potent molecules with different structural moieties were identified, and these molecules present new starting scaffolds for further improvement in terms of their potency and selectivity as PI3K inhibitors with the help of medicinal chemistry efforts. Furthermore, we also showed the significance of the interpretation and visualization of the model's predictions by the Grad-CAM technique, enhancing the robustness, transparency, and interpretability of the model's predictions. The data and script files and prediction run of models used for this study to reproduce the experiment are available in the GitHub repository at https://github.com/ravishankar1307/iDCNNPred.git .

2023-11-01·Gynecologic oncology

A randomized phase 2 study of sapanisertib in combination with paclitaxel versus paclitaxel alone in women with advanced, recurrent, or persistent endometrial cancer

Article

作者: Faller, Douglas V ; Han, Sileny N ; Makker, Vicky ; Jewell, Andrea ; Wenham, Robert M ; Alía, Eva María Guerra ; Sedarati, Farhad ; Vincent, Sylvie ; Raspagliesi, Francesco ; Neuwirth, Rachel ; Krell, Jonathan ; Baurain, Jean-François ; Su, Zhenqiang ; Braicu, Elena Ioana ; Oza, Amit ; Oaknin, Ana ; Scambia, Giovanni ; Colombo, Nicoletta

OBJECTIVE:

This phase 2 study investigated sapanisertib (selective dual inhibitor of mTORC1/2) alone, or in combination with paclitaxel or TAK-117 (a selective small molecule inhibitor of PI3K), versus paclitaxel alone in advanced, recurrent, or persistent endometrial cancer.

METHODS:

Patients with histologic diagnosis of endometrial cancer (1-2 prior regimens) were randomized to 28-day cycles on four treatment arms: 1) weekly paclitaxel 80 mg/m² (days 1, 8, and 15); 2) weekly paclitaxel 80 mg/m² + oral sapanisertib 4 mg on days 2-4, 9-11, 16-18, and 23-25; 3) weekly sapanisertib 30 mg, or 4) sapanisertib 4 mg + TAK-117 200 mg on days 1-3, 8-10, 15-17, and 22-24.

RESULTS:

Of 241 patients randomized, 234 received treatment (paclitaxel, n = 87 [3 ongoing]; paclitaxel+sapanisertib, n = 86 [3 ongoing]; sapanisertib, n = 41; sapanisertib+TAK-117, n = 20). The sapanisertib and sapanisertib+TAK-117 arms were closed to enrollment after futility analyses. After a median follow-up of 14.4 (paclitaxel) versus 17.2 (paclitaxel+sapanisertib) months, median progression-free survival (PFS; primary endpoint) was 3.7 versus 5.6 months (hazard ratio [HR] 0.82; 95% confidence interval [CI] 0.58-1.15; p = 0.139); in patients with endometrioid histology (n = 116), median PFS was 3.3 versus 5.7 months (HR 0.66; 95% CI 0.43-1.03). Grade ≥ 3 treatment-emergent adverse event rates were 54.0% with paclitaxel versus 89.5% paclitaxel+sapanisertib.

CONCLUSIONS:

Our findings support inclusion of chemotherapy combinations with investigational agents for advanced or metastatic disease. The primary endpoint was not met and toxicity was manageable.

TRIAL REGISTRATION:

ClinicalTrials.gov number, NCT02725268.

项与色雷利塞相关的新闻（医药）

2025-03-12

·Business Wire

Faeth Therapeutics and The GOG Foundation, Inc. (GOG-F) Launch First Phase 2 Combination Trial for Sapanisertib-Serabelisib in Patients With Endometrial Cancer

AUSTIN, Texas & PHILADELPHIA--(BUSINESS WIRE)--Faeth Therapeutics (Faeth), a clinical-stage biotechnology company focused on metabolism, and The GOG Foundation, Inc. (GOG-F), a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic malignancies, today announced the first patient has been dosed in its Phase 2 combination trial of PIKTOR, which is FTH-001 (serabelisib) and FTH-003 (sapanisertib) with paclitaxel. The trial is the most advanced of its kind to investigate a novel approach of dual PI3Kɑ-mTORC1/2 inhibition targeting cancer metabolism in patients with endometrial cancer. The PI3K/AKT/mTOR pathway is the most frequently mutated pathway in cancer and is essential for tumor metabolism. Endometrial cancer has the highest frequency of PI3K pathway mutations of any solid tumor, yet there are no approved therapies addressing this need. FTH-001, a PI3Kɑ inhibitor, and FTH-003, an mTORC 1/2 inhibitor, have both demonstrated potential in multiple previous cancer clinical trials and their combination represents a unique “multi-node” approach to targeting this pathway. The current study, An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, and a Substudy Evaluating PIKTOR With Paclitaxel Plus Diet, in Patients With Advanced or Recurrent Endometrial Cancer (FTH-PIK-201, GOG-3111)2 will expand on the strong Phase 1b data1 showing an 80% ORR in patients with endometrioid endometrial cancer with 11 months of progression-free survival. The Phase 2 study is based on Faeth’s metabolism-focused platform for developing novel therapeutic approaches. Endometrial cancer is one of the leading causes of cancer death in women and there is a high unmet need in patients with advanced and relapsed disease who have progressed after first line carboplatin-based therapy. “Thanks to Faeth’s ability to uncover novel metabolism-targeting strategies, we are positioned to leverage the PIKTOR approach for endometrial cancer and other solid tumors,” said Anand Parikh, J.D., Chief Executive Officer of Faeth Therapeutics. “Over its five decades, the GOG Foundation has established itself as a leading clinical partner against gynecologic cancers, and we are confident they will help us pave the way for the next generation of cancer treatments.” “This unique approach to target cancer metabolism has demonstrated impressive early results. We look forward to this trial to hopefully confirm these early findings and perhaps transform the way we treat patients with endometrial cancer,” said David Starks, MD, Principal Investigator and Associate Professor, Avera Cancer Institute and University of South Dakota Sanford School of Medicine. “Endometrial cancer is the leading cause of deaths among all gynecologic cancers. Finding better treatment options remains our highest priority. We are excited to partner with Faeth Therapeutics to further investigate this novel therapeutic approach,” said Brian Slomovitz, MD, Director, Gynecologic Oncology, Mount Sinai Medical Center and Uterine Cancer Trial Lead, GOG Partners. 1 Starks, David C. et al. “Phase I dose escalation study of dual PI3K/mTOR inhibition by Sapanisertib and Serabelisib in combination with paclitaxel in patients with advanced solid tumors.” Gynecologic Oncology, Volume 166, Issue 3, 403 – 409 2 https://clinicaltrials.gov/study/NCT06463028 About Faeth Therapeutics Faeth Therapeutics is a clinical-stage biotechnology company at the forefront of oncology research with a robust clinical and preclinical pipeline powered by its AI-driven MetabOS discovery platform. Faeth’s lead program, PIKTOR, has shown outstanding clinical results and is now in a Phase 2 trial for patients with endometrial cancer. For additional information, visit www.faeththerapeutics.com. About The GOG Foundation, Inc. (www.gog.org) The GOG Foundation, Inc. is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis, and distribution of results. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, and vulva. The GOG Foundation is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatisticians (including those with expertise in bioinformatics), basic scientists, quality of life experts, data managers, and administrative personnel. About GOG Partners Supported by industry, GOG Partners is structured to work directly with pharmaceutical organizations and operate clinical trials outside the National Cancer Institute (NCI) framework. The GOG Partners shares the same mission of the GOG Foundation dedicated to transforming the care in Gynecologic Oncology. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network. About Endometrial Cancer Endometrial cancer is the most common reproductive cancer affecting women within the United States, estimated to account for approximately 65,950 newly diagnosed cases in 2022. [ACS, 2022a] Although the average age at diagnosis for women with endometrial cancer is 60 years, a proportion of patients are diagnosed prior to menopause. [ACS, 2022a] Endometrial endometrioid adenocarcinoma is most commonly diagnosed when confined to the uterus, representing 67% of cases; however, the National Comprehensive Cancer Network (NCCN) reports that in 2017, 21% and 8% of cases were diagnosed as regional and distant diseases, respectively. [NCCN v1.2022c] Despite currently available treatment options, it was estimated that there would be nearly 12,550 endometrial cancer related deaths in the United States in 2022. [ACS, 2022b] Unfortunately, women with metastatic and recurrent endometrial cancer have unfavourable prognosis, with an estimated 5-year survival rate of 20%. [ACS, 2022b] aAmerican Cancer Society. Key Statistics for Endometrial Cancer. 2022, February 14. Accessed on August 4, 2022, from https://www.cancer.org/cancer/endometrial-cancer/about/key-statistics.html bAmerican Cancer Society. Survival Rates for Endometrial Cancer. 2022, February 28. Accessed August 3, 2022 from https://www.cancer.org/cancer/endometrial-cancer/detection-diagnosis-staging/survival-rates.html cNational Comprehensive Cancer Network. Uterine Neoplasms. Version 1.2022-November 4, 2021. Accessed on August 10, 2022, from https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf

临床2期临床1期

2024-05-30

·BioSpace

Faeth Therapeutics to Participate in Upcoming Jefferies Investor Conference

Faeth’s CEO to showcase how AI has unlocked metabolism as a new cancer treatment paradigm AUSTIN, Texas--(BUSINESS WIRE)-- Faeth Therapeutics, (Faeth) a clinical-stage biotechnology company, announced today that Anand Parikh, Chief Executive Officer (CEO), will participate in one-on-one investor meetings at the upcoming Jefferies Global Healthcare Conference being held June 4-6 in New York. To schedule a meeting at the conference with Faeth’s CEO, please contact bridie@faeththerapeutics.com. For more information about the conference, please contact your institutional sales representative at Jefferies. Founded by renowned oncology researchers including Drs. Lew Cantley, Siddhartha Mukherjee, and Karen Vousden alongside CEO Anand Parikh, Faeth is focused on developing therapies targeting cancer metabolism. The role of metabolism in cancer proliferation is well established, yet remains a vastly under-exploited area, with very few cancer metabolism therapies in existence today. Faeth’s differentiated approach to targeting cancer metabolism leverages a systemic understanding of cancer metabolism, functional genomics, and computational biology to develop effective, less toxic therapies. Faeth has a robust clinical and preclinical pipeline driven by the company’s MetabOS discovery platform, which leverages AI, machine learning, and curated data sets to identify targets matched to specific tumor genotypes. Faeth's lead program, FTH-001/003, or "PIKTOR," includes serabelisib, a PI3Kɑ inhibitor, and sapanisertib, an mTORC 1/2 inhibitor, which together effectively shut down the PI3K pathway, the most commonly mutated pathway in cancer. PIKTOR, together with paclitaxel, has already shown outstanding results in a Phase 1b trial including endometrial, ovarian, and breast cancers. Faeth's second clinical program features FTH-002, a specially formulated amino acid sachet, which is administered in conjunction with an amino acid-restricted regimen and radio/chemotherapy. About Faeth Therapeutics Faeth Therapeutics is a clinical-stage biotechnology company at the forefront of oncology research with a robust clinical and preclinical pipeline powered by its AI-driven MetabOS discovery platform. Faeth’s lead program, PIKTOR, has shown outstanding clinical results in a Phase 1b trial and is advancing into a Phase 2 trial in endometrial cancer in 2024. For additional information, visit .

临床1期临床2期临床结果

2024-05-29

·CPHI制药在线

罗氏Inavolisib获FDA突破性疗法认定， PI3Kα抑制剂持续发力晚期乳腺癌

关注并星标CPHI制药在线5月21日，罗氏宣布美国FDA授予其在研口服疗法inavolisib突破性疗法认定，通过与palbociclib（哌柏西利）和fulvestrant（氟维司群）联合使用，用于治疗PIK3CA突变、激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）、在完成辅助内分泌治疗后或12个月内复发的局部晚期或转移性乳腺癌成年患者。Inavolisib是新一代PI3K抑制剂，兼具高选择性抑制PI3Κα与特异性降解PI3Κα突变蛋白功能的独特双重作用机制。就在上个月，inavolisib已被CDE纳入优先审评程序。 FDA的决定是基于III期INAVO120研究阳性结果。INAVO120研究（NCT04191499）是一项全球、多中心、双盲、随机对照的III期临床研究，旨在评估Inavolisib联合哌柏西利和氟维司群在PIK3CA突变的HR+/HER2-局部晚期或转移性乳腺癌患者中的疗效和安全性。结果显示，对比哌柏西利+氟维司群对照组，Inavolisib的加入令中位PFS翻倍，由7.3个月延长至15个月，具有统计学意义和临床意义的改善，并降低了57%的疾病进展或死亡风险（HR= 0.43，95%CI 0.32-0.59；p<0.0001）。在客观缓解率（ORR）和临床获益率（CBR）方面也观察到明显优势，Inavolisib+哌柏西利+氟维司群组ORR达58.4%，比对照组提高了33.4%（58.4% vs. 25.0%）；CBR达到了75.2%，比对照组提高了28.2%（75.2% vs. 47.0% ）。虽然OS方面虽然数据尚未成熟，但已观察到获益趋势。此外，inavolisib也在同步开展其他2项III期临床研究，分别是联合氟维司群 vs. alpelisib联合氟维司群用于既往接受过CDK4/6抑制剂和内分泌联合治疗的HR阳性/HER2阴性乳腺癌患者的INAVO121研究、联合帕妥珠单抗曲妥珠单抗皮下注射复方Phesgo）vs. Phesgo作为HER2阳性乳腺癌患者一线维持治疗的INAVO122研究。 PIK3CA基因与乳腺癌耐药 PAM通路中的PI3K是一种胞内磷脂酰肌醇激酶，又称磷脂酰肌醇3-激酶。它是一种二聚物体复合物，由催化亚基和调节亚基构成，根据不同的结构特点和底物分子可分为三类。其中研究最广泛的为I类PI3K，又分为IA类和IB类两个主要亚类。IA类PI3K包括PI3Kα、PI3Kβ、PI3Kδ，由其相对应的催化亚基p110（p110α、p110β、p110δ）和调节亚基p85组成。而PIK3CA基因可编码P110α蛋白，该蛋白在PIK3CA突变驱动的肿瘤生长和乳腺癌治疗耐药中发挥重要作用。CDK4/6抑制剂联合雌激素受体(ER)降解剂氟维司特可显著提高晚期激素受体阳性(HR+)乳腺癌患者的无进展生存期和总生存期，这是该疾病的标准治疗方法。然而，这种组合用药并不能治愈HR+乳腺癌患者，耐药性限制了临床受益的持续时间。在高达40%的HR+乳腺癌中，PIK3CA突变导致磷酸肌醇3-激酶α (PI3Kα)的激活，是耐药的关键驱动因素。因此，PI3Kα抑制剂联合CDK4/6抑制剂和/或氟维司特在预防和克服HR+、PIK3CA突变型乳腺癌的治疗耐药方面具有很高的市场价值。图片来源：参考来源2 Alpelisib将迎来Inavolisib正面PK 尽管PI3K抑制剂（包括选择性抑制剂与泛抑制剂）在血液瘤领域遭遇频繁撤市，但并未影响PI3Kα抑制剂在实体瘤领域的持续探索。诺华的Alpelisib（Piqray）是目前全球唯一获批上市的PI3Kα抑制，Piqray适应症为联合氟维司群治疗HR+/HER2-伴有PIK3CA突变的晚期或转移性乳腺癌。此后，alpelisib还在罕见病领域成功获批了第二项适应症，用于治疗PIK3CA相关过度生长疾病谱系（PROS）成人和2岁及以上儿童患者，alpelisib 2023年销售额达到5亿美元。值得注意的是，在NCCN指南中alpelisib联合氟维司群方案仅作为二线以及后线治疗推荐。而罗氏III期临床明确inavolisib组合作为一线治疗方案，瞄准的是患者群体更大的药物市场。换句话说，在当前获批的适应症下，inavolisib上市后的市场并不会受到alpelisib的影响，而因为患者在一线治疗已经使用了PI3Kα抑制剂，则有可能会影响临床医生二线治疗方案时再选择PI3Kα抑制剂，将会对alpelisib的市场造成冲击。此外，如上文所提及罗氏也开展了inavolisib与alpelisib的头对头研究，未来也将在二线及以上治疗市场中与alpelisib展开正面较量。由于alpelisib对wt和突变型PI3Kα均有抑制作用，选择性较差，临床中出现严重的高血糖副作用，65%患者出现高血糖，其中37%为3-4级AE。Inavolisib在III期临床中，有6.5%患者出现3-4级高血糖AE，这一点inavolisib有明显的优势。高达40%的HR+/HER2-晚期乳腺癌患者存在PIK3CA突变，在这一突变人群中inavolisib对比一线标准疗法，mPFS延长一倍以上（15.0个月vs7.3个月），拥有碾压性的临床优势，商业化前景可期。不仅是HER2阴性，罗氏同样在HER2阳性乳腺癌中联用帕妥珠/曲妥珠单抗一线维持开展了III期头对头研究，同样也是值得期待的大适应症。诺华和罗氏的接连成功，自然也吸引了很多药企开发选择性PI3Kα抑制剂，进入临床阶段的有Petra Pharm的Serabelisib、礼来的LOXO-783和Relay Therapeutics的RLY-2608等。国内方面，涉及到PI3Kα抑制剂研发的企业则有上海海和的CYH33、豪森的HS-10352和君实/润佳的JS105等。适应症包括晚期实体瘤、乳腺癌和复发/持续性卵巢、输卵管或原发性腹膜透明细胞癌等。进入临床阶段的高选择性PI3Kα抑制剂整理参考来源 1. André F, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380(20):1929-40 2. Overview of the relevance of PI3K pathway in HR-positive breast cancer. N Vasan, et al. Ann Oncol. 2019 Dec 1;30(Suppl_10):x3-x11. 3. He Y, et al. Targeting PI3K/Akt signal transduction for cancer therapy. Signals Transduction and Targeted Therapy. 2021; 6: 425 4. Juric et al. A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA-mutated hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer. Presented at San Antonio Breast Cancer Symposium, 2020 December 7-10; San Antonio, USA. Abstract #P5-17-05 5. Jhaveri K et al. Phase III study of inavolisib or placebo in combination with palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer: INAVO120 primary analysis. Presented at San Antonio Breast Cancer Symposium, 2023 December 5-9; San Antonio, USA. Abstract #GS03-13【企业推荐】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

突破性疗法优先审批临床3期临床结果

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外链

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
子宫内膜样腺癌	临床2期	美国	Faeth Therapeutics, Inc.	2024-12-12
结直肠癌	临床2期	-	Petra Pharma Corp.	2020-09-01
子宫内膜癌	临床2期	-	Petra Pharma Corp.	2020-09-01
头颈部肿瘤	临床2期	-	Petra Pharma Corp.	2020-09-01
局部晚期恶性实体瘤	临床2期	-	Petra Pharma Corp.	2020-09-01
肺癌	临床2期	-	Petra Pharma Corp.	2020-09-01
PIK3CA突变的乳腺癌	临床2期	-	Petra Pharma Corp.	2020-09-01
转移性三阴性乳腺癌	临床2期	美国	Takeda Pharmaceutical Co., Ltd.	2017-07-18
转移性透明细胞性肾细胞癌	临床2期	美国	Millennium Pharmaceuticals, Inc.	2016-06-30
转移性透明细胞性肾细胞癌	临床2期	加拿大	Millennium Pharmaceuticals, Inc.	2016-06-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03154294 (CTgov)	临床1期	晚期恶性实体瘤	19	paclitaxel+TAK-117+TAK-228 (Cohort 1)	衊顧艱壓夢遞網鹹壓獵 = 顧淵鏇遞淵繭壓獵遞衊夢廠廠簾襯繭壓餘廠鬱 (觸夢願醖遞遞窪網醖鹹, 艱窪淵憲壓壓淵觸餘築 ~ 鹽衊醖遞廠壓簾鹽膚製) 更多	-	2024-07-26
				paclitaxel+TAK-117+TAK-228 (Cohort 2)	衊顧艱壓夢遞網鹹壓獵 = 鬱廠構憲築構鹹醖窪鹹夢廠廠簾襯繭壓餘廠鬱 (觸夢願醖遞遞窪網醖鹹, 觸襯襯鏇廠網鏇齋壓製 ~ 夢觸構製襯選醖襯鏇製) 更多
NCT03193853 (CTgov)	临床2期	转移性三阴性乳腺癌	12	Nab Paclitaxel+Cisplatin+Tak-117+Tak-228	築鹹齋鬱衊蓋醖範壓願 = 築夢衊餘觸膚廠遞築艱築壓鬱淵蓋繭醖網簾鏇 (積遞願夢製廠願壓觸鹽, 顧築淵窪窪餘餘觸鹽鹹 ~ 壓鬱簾艱鹽築糧蓋鏇憲) 更多	-	2023-05-09
NCT03154294 (ASCO 12021 \| ASCO 22021) 人工标引	临床1期	卵巢癌 \| 子宫内膜癌 \| 乳腺癌 PI3K Mutation \| AKT Mutation \| MTOR Mutation	19	paclitaxel+sapanisertib+serabelisib	壓廠簾鹹鑰淵繭衊觸構(願積鏇膚膚觸襯築艱蓋) = 顧築衊淵築艱願顧糧餘夢膚襯築觸襯糧淵糧簾 (糧醖齋觸襯鹽膚築廠鬱 ) 更多	积极	2021-05-20
NCT02724020 (CTgov)	临床2期	转移性透明细胞性肾细胞癌	96	everolimus (Arm A: Single-agent Everolimus 10 mg QD)	範製齋繭艱觸積鬱選餘(衊製夢餘鬱齋壓齋觸獵) = 獵範願遞淵網夢繭積廠願衊積繭鏇襯鏇淵夢繭 (夢艱遞簾鹹壓艱齋積簾, 壓憲遞蓋選憲鏇淵範範 ~ 淵衊鑰壓簾鏇網糧遞簾) 更多	-	2021-02-21
				MLN0128 (Arm B: Single-agent MLN0128 30 mg QW)	範製齋繭艱觸積鬱選餘(衊製夢餘鬱齋壓齋觸獵) = 膚鹽鬱製糧鏇餘製淵夢願衊積繭鏇襯鏇淵夢繭 (夢艱遞簾鹹壓艱齋積簾, 壓積簾積簾鬱淵齋齋獵 ~ 壓網願範遞願選醖鹽遞) 更多
NCT02725268 (phase 2 study of sapanisertib in combination with paclitaxel versus paclitaxel alone in women with advanced, recurrent, or persistent endometrial cancer, CTgov)	临床2期	复发性子宫内膜癌	241	Paclitaxel (Paclitaxel 80 mg/m^2)	膚顧蓋選選築艱憲顧築(膚艱艱鏇醖鏇壓膚艱鹽) = 夢淵廠夢夢餘遞願廠餘齋築製鏇鑰遞簾壓衊蓋 (膚膚廠淵鏇獵顧憲遞觸, 艱遞積壓鬱夢襯鬱醖艱 ~ 獵遞膚製鹽鏇顧觸壓蓋) 更多	-	2020-06-09
				Paclitaxel+Sapanisertib (Paclitaxel 80 mg/m^2 + Sapanisertib 4 mg)	膚顧蓋選選築艱憲顧築(膚艱艱鏇醖鏇壓膚艱鹽) = 網廠襯衊願壓膚選醖壓齋築製鏇鑰遞簾壓衊蓋 (膚膚廠淵鏇獵顧憲遞觸, 壓艱廠蓋積憲製顧壓衊 ~ 鬱網醖獵廠衊顧顧襯築) 更多
NCT01449370 (ASCO2015)	临床1期	晚期恶性实体瘤	76	MLN1117 once daily (QD)	窪鹹築膚鏇選簾網範積(簾觸艱觸鏇鹽衊廠醖願) = 夢選衊膚窪鏇窪膚積網蓋構廠鏇衊觸製鏇鑰獵 (獵餘夢鬱醖繭遞艱壓醖 ) 更多	-	2015-05-20
				MLN1117 3 days per week (MWF)	窪鹹築膚鏇選簾網範積(簾觸艱觸鏇鹽衊廠醖願) = 夢襯鏇選選觸獵製餘膚蓋構廠鏇衊觸製鏇鑰獵 (獵餘夢鬱醖繭遞艱壓醖 ) 更多