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临床试验/NCT07492680
NCT07492680招募中2 期

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

Bristol-Myers Squibb130 个研究点 分布在 13 个国家目标入组 260 人开始时间: 2026年7月27日最近更新:
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适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
260
试验地点
130
主要终点
Part 1: Number of participants who achieve Objective Response (OR)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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-986504 alone and in combination regimens.

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.
  • •Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

排除标准

  • •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 within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) 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.

研究组 & 干预措施

Part 2: Cohort 2c

Experimental

BMS-986504 + Daraxonrasib + Chemotherapy

干预措施: Gemcitabine (Drug)

Part 2: Cohort 4

Experimental

BMS-986504 + Temozolomide + Radiotherapy

干预措施: BMS-986504 (Drug)

Part 2: Cohort 2a

Experimental

BMS-986504 + Daraxonrasib

干预措施: Daraxonrasib (Drug)

Part 2: Cohort 2b

Experimental

BMS-986504 + Daraxonrasib

干预措施: Daraxonrasib (Drug)

Part 2: Cohort 2a

Experimental

BMS-986504 + Daraxonrasib

干预措施: BMS-986504 (Drug)

Part 2: Cohort 1

Experimental

BMS-986504 + Pumitamig + Chemotherapy

干预措施: Pemetrexed (Drug)

Part 2: Cohort 1

Experimental

BMS-986504 + Pumitamig + Chemotherapy

干预措施: Pumitamig (Drug)

Part 2: Cohort 1

Experimental

BMS-986504 + Pumitamig + Chemotherapy

干预措施: Carboplatin (Drug)

Part 1a

Experimental

BMS-986504

干预措施: BMS-986504 (Drug)

Part 2: Cohort 2c

Experimental

BMS-986504 + Daraxonrasib + Chemotherapy

干预措施: Daraxonrasib (Drug)

Part 2: Cohort 1

Experimental

BMS-986504 + Pumitamig + Chemotherapy

干预措施: BMS-986504 (Drug)

Part 2: Cohort 2c

Experimental

BMS-986504 + Daraxonrasib + Chemotherapy

干预措施: BMS-986504 (Drug)

Part 1b

Experimental

BMS-986504

干预措施: BMS-986504 (Drug)

Part 2: Cohort 4

Experimental

BMS-986504 + Temozolomide + Radiotherapy

干预措施: Temozolomide (Drug)

Part 2: Cohort 3

Experimental

BMS-986504 + Nivolumab + Relatlimab FDC

干预措施: Nivolumab + Relatlimab FDC (Drug)

Part 2: Cohort 2b

Experimental

BMS-986504 + Daraxonrasib

干预措施: BMS-986504 (Drug)

Part 2: Cohort 1

Experimental

BMS-986504 + Pumitamig + Chemotherapy

干预措施: Nab-paclitaxel (Drug)

Part 2: Cohort 3

Experimental

BMS-986504 + Nivolumab + Relatlimab FDC

干预措施: BMS-986504 (Drug)

Part 2: Cohort 2c

Experimental

BMS-986504 + Daraxonrasib + Chemotherapy

干预措施: Nab-paclitaxel (Drug)

Part 2: Cohort 1

Experimental

BMS-986504 + Pumitamig + Chemotherapy

干预措施: Paclitaxel (Drug)

结局指标

主要结局

Part 1: Number of participants who achieve Objective Response (OR)

时间窗: Up to approximately 2 years

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

Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria

时间窗: Up to approximately 2 years

Part 2: Number of participants with adverse events (AE)

时间窗: Up to approximately 2 years

Part 2: Number of participants with Serious AEs (SAEs)

时间窗: Up to approximately 2 years

Part 2: Number of participants with treatment related AEs

时间窗: Up to approximately 2 years

Part 2: Number of participants with treatment related SAEs

时间窗: Up to approximately 2 years

Part 2: Number of participants with AEs leading to study treatment discontinuation

时间窗: Up to approximately 2 years

Part 2: Number of participants with AEs leading to death

时间窗: Up to approximately 2 years

Part 2: Number of participants with laboratory abnormalities

时间窗: Up to approximately 2 years

次要结局

  • Part 1 and 2: Time to objective response (TTOR)(Up to approximately 2 years)
  • Part 1 and 2: Duration of response (DOR)(Up to approximately 2 years)
  • Part 1 and 2: Number of participants who achieve disease control (DC)(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)(Up to approximately 2 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (130)

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A Study of BMS-986504 Monotherapy and in Combination... | 临床试验