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百时美施贵宝A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) II期 260 开放性试验
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临床试验NCT07492680旨在研究治疗，主要针对实体肿瘤。这是一项II期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年7月17日开始，预计招募260名患者。该研究由百时美施贵宝主导，计划于2032年5月20日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月25日。
简要概括
This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-98650...显示更多
详细描述
Part 1 will include parallel enrolment of tumor-specific dose-expansion cohorts evaluating BMS-986504 as monotherapy. Part 2 will include dose-escalation cohorts in which BMS-986504 is given in combination with other anticancer agents. Additional cohorts may be added based on emerging data.
官方标题
A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion
疾病
实体肿瘤其他研究标识符
- CA240-0005
- 2025-524285-18 (其他标识符) (EU CTR)
- U1111-1330-1428 (其他标识符) (WHO)
NCT编号
实际开始日期
2026-07-17
最近更新发布
2026-03-25
预计完成日期
2032-05-20
计划入组人数
260
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
尚未招募
关键词
MTAP
CDKN2A
PRMT5
MountainTAP
Targeted therapy
Brain cancer
GBM
Melanoma
NSCLC
Lung cancer PDAC
Pancreatic cancer
Navlimetostat
Navli
CDKN2A
PRMT5
MountainTAP
Targeted therapy
Brain cancer
GBM
Melanoma
NSCLC
Lung cancer PDAC
Pancreatic cancer
Navlimetostat
Navli
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Part 1a | BMS-986504 Specified dose on specified days |
实验性Part 1b | BMS-986504 Specified dose on specified days |
实验性Part 2: Cohort 1 BMS-986504 + Pumitamig + Chemotherapy | BMS-986504 Specified dose on specified days Pumitamig Specified dose on specified days Pemetrexed Specified dose on specified days 卡铂 Specified dose on specified days Nab-paclitaxel Specified dose on specified days Paclitaxel Specified dose on specified days |
实验性Part 2: Cohort 2a BMS-986504 + Pan-RAS inhibitor | BMS-986504 Specified dose on specified days Daraxonrasib Specified dose on specified days |
实验性Part 2: Cohort 2b BMS-986504 + Pan-RAS inhibitor | BMS-986504 Specified dose on specified days Daraxonrasib Specified dose on specified days |
实验性Part 2: Cohort 2c BMS-986504 + Pan-RAS inhibitor + Chemotherapy | BMS-986504 Specified dose on specified days Daraxonrasib Specified dose on specified days Nab-paclitaxel Specified dose on specified days Gemcitabine Specified dose on specified days |
实验性Part 2: Cohort 3 BMS-986504 + Nivolumab + Relatlimab FDC | BMS-986504 Specified dose on specified days Nivolumab + Relatlimab FDC Specified dose on specified days |
实验性Part 2: Cohort 4 BMS-986504 + Temozolomide + Radiotherapy | BMS-986504 Specified dose on specified days 替莫唑胺 Specified dose on specified days |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Part 1: Number of participants who achieve Objective Response (OR) | OR is defined as confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Response Assessment in Neuro-Oncology (RANO) v2 or Modified RECIST v1.1 | Up to approximately 2 years |
Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria | Up to approximately 2 years | |
Part 2: Number of participants with adverse events (AE) | Up to approximately 2 years | |
Part 2: Number of participants with Serious AEs (SAEs) | Up to approximately 2 years | |
Part 2: Number of participants with treatment related AEs | Up to approximately 2 years | |
Part 2: Number of participants with treatment related SAEs | Up to approximately 2 years | |
Part 2: Number of participants with AEs leading to study treatment discontinuation | Up to approximately 2 years | |
Part 2: Number of participants with AEs leading to death | Up to approximately 2 years | |
Part 2: Number of participants with laboratory abnormalities | Up to approximately 2 years |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Part 1 and 2: Time to objective response (TTOR) | Defined as time from first dose to the date of the first documentation of objective tumor response (CR or PR) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1 | Up to approximately 2 years |
Part 1 and 2: Duration of response (DOR) | Defined as the time between the date of the first documentation of objective tumor response (CR or PR) and the date of disease progression or to death from any cause (whichever occurs first) by RECIST v1.1. or RANO v2 or Modified RECIST v1.1 | Up to approximately 2 years |
Part 1 and 2: Number of participants who achieve disease control (DC) | Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD) for at least 4 months after start of treatment) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1 | Up to approximately 2 years |
Part 1: Number of participants with adverse events (AE) | Up to approximately 2 years | |
Part 1: Number of participants with Serious AEs (SAEs) | Up to approximately 2 years | |
Part 1: Number of participants with treatment related AEs | Up to approximately 2 years | |
Part 1: Number of participants with treatment related SAEs | Up to approximately 2 years | |
Part 1: Number of participants with AEs leading to study treatment discontinuation | Up to approximately 2 years | |
Part 1: Number of participants with AEs leading to death | Up to approximately 2 years | |
Part 1: Number of participants with laboratory abnormalities | Up to approximately 2 years | |
Part 2: Number of participants who achieve Objective Response (OR) | Up to approximately 2 years | |
Part 1 and 2: Number of participants who achieved clinical benefit (CB) | CB defined as BOR of confirmed CR, confirmed PR, or SD for at least 4 months after start of treatment by RECIST v1.1 or RANO v2 | Up to approximately 2 years |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
- Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.
- Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.
- Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) should be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer should be ≤ 2 × ULN.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.
- Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
- Participants must not have history of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
- Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.
- Participants must not have active viral HBV or HCV hepatitis.
Other protocol defined inclusion/exclusion criteria applies.
百时美施贵宝448 个活跃的临床试验可供探索研究中心联系人
联系人: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, [email protected]
联系人: First line of the email MUST contain NCT # and Site #.
55 位于 13 个国家/地区的研究中心
Beijing Municipality
Local Institution - 0155, Beijing, Beijing Municipality, 100071, China
Site 0155, 联系人
Shanghai Municipality
Local Institution - 0153, Shanghai, Shanghai Municipality, 200032, China
Site 0153, 联系人
Local Institution - 0156, Shanghai, Shanghai Municipality, 200131, China
Site 0156, 联系人
Local Institution - 0063, Shatin, NT, Hong Kong
Site 0063, 联系人
California
Local Institution - 0096, San Francisco, California, 94158, United States
Site 0096, 联系人
Colorado
Local Institution - 0182, Aurora, Colorado, 80045, United States
Site 0182, 联系人
Florida
Local Institution - 0122, Tampa, Florida, 33612, United States
Georgia
Local Institution - 0178, Atlanta, Georgia, 30322, United States
Site 0178, 联系人
Illinois
Local Institution - 0106, Chicago, Illinois, 60637, United States
Site 0106, 联系人
Maryland
Local Institution - 0143, Baltimore, Maryland, 21287, United States
Site 0143, 联系人
Massachusetts
Local Institution - 0124, Boston, Massachusetts, 02114, United States
Site 0124, 联系人
Michigan
Local Institution - 0119, Ann Arbor, Michigan, 48109-0922, United States
Site 0119, 联系人
Minnesota
Local Institution - 0129, Rochester, Minnesota, 55905, United States
Site 0129, 联系人
Local Institution - 0174, Rochester, Minnesota, 55905, United States
Site 0174, 联系人
Local Institution - 0181, Rochester, Minnesota, 55905, United States
Site 0181, 联系人
New York
Local Institution - 0142, Buffalo, New York, 14263, United States
Site 0142, 联系人
Local Institution - 0170, New York, New York, 10016, United States
Site 0170, 联系人
Local Institution - 0139, New York, New York, 10021, United States
Site 0139, 联系人
North Carolina
Local Institution - 0100, Durham, North Carolina, 27705, United States
Site 0100, 联系人
Texas
Local Institution - 0085, Houston, Texas, 77030, United States
Site 0085, 联系人
Washington
Local Institution - 0086, Seattle, Washington, 98109, United States
Site 0086, 联系人
Wisconsin
Local Institution - 0134, Madison, Wisconsin, 53792, United States
Site 0134, 联系人
Oost-Vlaanderen
Local Institution - 0114, Ghent, Oost-Vlaanderen, 9000, Belgium
Site 0114, 联系人
British Columbia
Local Institution - 0051, Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
Site 0051, 联系人
Ontario
Local Institution - 0021, Toronto, Ontario, M4N 3M5, Canada
Site 0021, 联系人
Local Institution - 0007, Toronto, Ontario, M5G 2M9, Canada
Site 0007, 联系人
Côte-d'Or
Local Institution - 0078, Dijon, Côte-d'Or, 21079, France
Site 0078, 联系人
Rhône
Local Institution - 0075, Pierre-Bénite, Rhône, 69310, France
Site 0075, 联系人
Val-de-Marne
Local Institution - 0116, Villejuif, Val-de-Marne, 94800, France
Site 0116, 联系人
Local Institution - 0074, Paris, 75010, France
Site 0074, 联系人
Rhineland-Palatinate
Local Institution - 0081, Mainz, Rhineland-Palatinate, 55131, Germany
Site 0081, 联系人
Local Institution - 0040, Hamburg, 20246, Germany
Site 0040, 联系人
Local Institution - 0039, Heidelberg, 69120, Germany
Site 0039, 联系人
Local Institution - 0061, Leipzig, 04103, Germany
Site 0061, 联系人
Local Institution - 0049, München, 81675, Germany
Site 0049, 联系人
Local Institution - 0047, Würzburg, 97080, Germany
Site 0047, 联系人
Local Institution - 0080, Cork, T12 E8YV, Ireland
Site 0080, 联系人
Local Institution - 0023, Dublin, 7, Ireland
Site 0023, 联系人
Local Institution - 0146, Dublin, D08 E9P6, Ireland
Site 0146, 联系人
Tuscany
Local Institution - 0073, Siena, Tuscany, 53100, Italy
Site 0073, 联系人
Local Institution - 0123, Bergamo, 24127, Italy
Site 0123, 联系人
Local Institution - 0034, Milan, 20133, Italy
Site 0034, 联系人
Local Institution - 0050, Naples, 80131, Italy
Site 0050, 联系人
Local Institution - 0082, Perugia, 06156, Italy
Site 0082, 联系人
Tokyo
Local Institution - 0020, Chuo-ku, Tokyo, 104-0045, Japan
Site 0020, 联系人
Hordaland
Local Institution - 0171, Bergen, Hordaland, 5021, Norway
Site 0171, 联系人
Local Institution - 0022, Oslo, 0450, Norway
Site 0022, 联系人
Seoul-teukbyeolsi [Seoul]
Local Institution - 0004, Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Site 0004, 联系人
Local Institution - 0058, Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea
Site 0058, 联系人
Local Institution - 0052, Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Site 0052, 联系人
Barcelona [Barcelona]
Local Institution - 0068, Barcelona, Barcelona [Barcelona], 08035, Spain
Site 0068, 联系人
Local Institution - 0071, Hospitalet, Barcelona [Barcelona], 08907, Spain
Site 0071, 联系人
Local Institution - 0033, Madrid, 28028, Spain
Site 0033, 联系人
Local Institution - 0059, Madrid, 28034, Spain
Site 0059, 联系人
Local Institution - 0069, Seville, 41013, Spain
Site 0069, 联系人