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브리스톨-마이어스 스퀴브A 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) 2상 260 오픈 라벨
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07492680은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 고형 종양들에 대해 진행되며, 2상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2026년 7월 17일부터 가능하며, 260명의 참여자를 모집할 예정입니다. 브리스톨-마이어스 스퀴브이(가) 진행하는 이 연구는 2032년 5월 20일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 25일에 갱신되었습니다.
간단한 개요
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...더 보기
상세한 설명
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.
공식 제목
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
질환명
고형 종양들기타 연구 식별자
- CA240-0005
- 2025-524285-18 (기타 식별자) (EU CTR)
- U1111-1330-1428 (기타 식별자) (WHO)
NCT 번호
실제 연구 시작일
2026-07-17
최신 업데이트 게시
2026-03-25
예상 연구 완료일
2032-05-20
계획된 등록 인원
260
연구종류
중재연구
단계/상
2상
상태
대상자모집전
키워드
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
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Part 1a | BMS-986504 Specified dose on specified days |
실험적Part 1b | BMS-986504 Specified dose on specified days |
실험적Part 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 카보플라틴 Specified dose on specified days Nab-paclitaxel Specified dose on specified days Paclitaxel Specified dose on specified days |
실험적Part 2: Cohort 2a BMS-986504 + Pan-RAS inhibitor | BMS-986504 Specified dose on specified days Daraxonrasib Specified dose on specified days |
실험적Part 2: Cohort 2b BMS-986504 + Pan-RAS inhibitor | BMS-986504 Specified dose on specified days Daraxonrasib Specified dose on specified days |
실험적Part 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 |
실험적Part 2: Cohort 3 BMS-986504 + Nivolumab + Relatlimab FDC | BMS-986504 Specified dose on specified days Nivolumab + Relatlimab FDC Specified dose on specified days |
실험적Part 2: Cohort 4 BMS-986504 + Temozolomide + Radiotherapy | BMS-986504 Specified dose on specified days 테모졸로마이드 Specified dose on specified days |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- 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.
브리스톨-마이어스 스퀴브448개의 진행 중인 임상시험 탐색 가능연구 대표 연락처
연락처: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, [email protected]
연락처: First line of the email MUST contain NCT # and Site #.
55 13개국에 임상시험 장소
Seoul-teukbyeolsi [Seoul]
Local Institution - 0004, Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Site 0004, 연락처
Local Institution - 0058, Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea
Site 0058, 연락처
Local Institution - 0052, Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Site 0052, 연락처
California
Local Institution - 0096, San Francisco, California, 94158, United States
Site 0096, 연락처
Colorado
Local Institution - 0182, Aurora, Colorado, 80045, United States
Site 0182, 연락처
Florida
Local Institution - 0122, Tampa, Florida, 33612, United States
Georgia
Local Institution - 0178, Atlanta, Georgia, 30322, United States
Site 0178, 연락처
Illinois
Local Institution - 0106, Chicago, Illinois, 60637, United States
Site 0106, 연락처
Maryland
Local Institution - 0143, Baltimore, Maryland, 21287, United States
Site 0143, 연락처
Massachusetts
Local Institution - 0124, Boston, Massachusetts, 02114, United States
Site 0124, 연락처
Michigan
Local Institution - 0119, Ann Arbor, Michigan, 48109-0922, United States
Site 0119, 연락처
Minnesota
Local Institution - 0129, Rochester, Minnesota, 55905, United States
Site 0129, 연락처
Local Institution - 0174, Rochester, Minnesota, 55905, United States
Site 0174, 연락처
Local Institution - 0181, Rochester, Minnesota, 55905, United States
Site 0181, 연락처
New York
Local Institution - 0142, Buffalo, New York, 14263, United States
Site 0142, 연락처
Local Institution - 0170, New York, New York, 10016, United States
Site 0170, 연락처
Local Institution - 0139, New York, New York, 10021, United States
Site 0139, 연락처
North Carolina
Local Institution - 0100, Durham, North Carolina, 27705, United States
Site 0100, 연락처
Texas
Local Institution - 0085, Houston, Texas, 77030, United States
Site 0085, 연락처
Washington
Local Institution - 0086, Seattle, Washington, 98109, United States
Site 0086, 연락처
Wisconsin
Local Institution - 0134, Madison, Wisconsin, 53792, United States
Site 0134, 연락처
Oost-Vlaanderen
Local Institution - 0114, Ghent, Oost-Vlaanderen, 9000, Belgium
Site 0114, 연락처
British Columbia
Local Institution - 0051, Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
Site 0051, 연락처
Ontario
Local Institution - 0021, Toronto, Ontario, M4N 3M5, Canada
Site 0021, 연락처
Local Institution - 0007, Toronto, Ontario, M5G 2M9, Canada
Site 0007, 연락처
Beijing Municipality
Local Institution - 0155, Beijing, Beijing Municipality, 100071, China
Site 0155, 연락처
Shanghai Municipality
Local Institution - 0153, Shanghai, Shanghai Municipality, 200032, China
Site 0153, 연락처
Local Institution - 0156, Shanghai, Shanghai Municipality, 200131, China
Site 0156, 연락처
Côte-d'Or
Local Institution - 0078, Dijon, Côte-d'Or, 21079, France
Site 0078, 연락처
Rhône
Local Institution - 0075, Pierre-Bénite, Rhône, 69310, France
Site 0075, 연락처
Val-de-Marne
Local Institution - 0116, Villejuif, Val-de-Marne, 94800, France
Site 0116, 연락처
Local Institution - 0074, Paris, 75010, France
Site 0074, 연락처
Rhineland-Palatinate
Local Institution - 0081, Mainz, Rhineland-Palatinate, 55131, Germany
Site 0081, 연락처
Local Institution - 0040, Hamburg, 20246, Germany
Site 0040, 연락처
Local Institution - 0039, Heidelberg, 69120, Germany
Site 0039, 연락처
Local Institution - 0061, Leipzig, 04103, Germany
Site 0061, 연락처
Local Institution - 0049, München, 81675, Germany
Site 0049, 연락처
Local Institution - 0047, Würzburg, 97080, Germany
Site 0047, 연락처
Local Institution - 0063, Shatin, NT, Hong Kong
Site 0063, 연락처
Local Institution - 0080, Cork, T12 E8YV, Ireland
Site 0080, 연락처
Local Institution - 0023, Dublin, 7, Ireland
Site 0023, 연락처
Local Institution - 0146, Dublin, D08 E9P6, Ireland
Site 0146, 연락처
Tuscany
Local Institution - 0073, Siena, Tuscany, 53100, Italy
Site 0073, 연락처
Local Institution - 0123, Bergamo, 24127, Italy
Site 0123, 연락처
Local Institution - 0034, Milan, 20133, Italy
Site 0034, 연락처
Local Institution - 0050, Naples, 80131, Italy
Site 0050, 연락처
Local Institution - 0082, Perugia, 06156, Italy
Site 0082, 연락처
Tokyo
Local Institution - 0020, Chuo-ku, Tokyo, 104-0045, Japan
Site 0020, 연락처
Hordaland
Local Institution - 0171, Bergen, Hordaland, 5021, Norway
Site 0171, 연락처
Local Institution - 0022, Oslo, 0450, Norway
Site 0022, 연락처
Barcelona [Barcelona]
Local Institution - 0068, Barcelona, Barcelona [Barcelona], 08035, Spain
Site 0068, 연락처
Local Institution - 0071, Hospitalet, Barcelona [Barcelona], 08907, Spain
Site 0071, 연락처
Local Institution - 0033, Madrid, 28028, Spain
Site 0033, 연락처
Local Institution - 0059, Madrid, 28034, Spain
Site 0059, 연락처
Local Institution - 0069, Seville, 41013, Spain
Site 0069, 연락처