Phase 1/2a First in Human Study of BMS-986277 Administered Alone and in Combination With Nivolumab in Advanced Epithelial Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Number of Participants With a Serious Adverse Event (SAE)
研究概览
简要总结
The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3
- •Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be accessible for biopsy in addition to the target lesion
- •Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment
- •ECOG performance status less than or equal to 2
排除标准
- •Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease
- •Participants with carcinomatous meningitis
- •Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment
- •Participants with active, known, or suspected autoimmune disease
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Number of Participants With a Serious Adverse Event (SAE)
时间窗: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced a SAE during the course of the study.
Number of Participants With an Adverse Event (AE)
时间窗: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced an AE during the course of the study.
Number of Participants With an Adverse Event (AE) Leading to Discontinuation
时间窗: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced an AE leading to discontinuation during the course of the study.
Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria
时间窗: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced an AE meeting protocol-defined DLT criteria during the course of the study.
Number of Participants With an Adverse Event (AE) Leading to Death
时间窗: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced an AE leading to death during the course of the study.
Number of Participants With a Clinical Laboratory Test Abnormality
时间窗: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced a clinical laboratory test abnormality during the course of the study.
Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers
时间窗: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced a vital sign abnormality or other safety biomarkers during the course of the study.
次要结局
- Disease Control Rate (DCR)(at Weeks 8, 16 and 24)
- Cmax(Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits)
- AUC(0-T)(Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits)
- Objective Response Rate (ORR)(at Weeks 8, 16 and 24)
- Median Duration of Response (mDOR)(at Weeks 8, 16 and 24)
- Median Progression-Free Survival (mPFS)(at Weeks 8, 16 and 24, to progression)
- AUC(INF)(Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits)
- Vss(Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits)
- Progression-Free Survival Rate (PFSR)(at Weeks 8, 16 and 24)
- Tmax(Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits)
- T-HALF(Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits)
- CLT(Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits)
- AUC(0-48)(Cycle 1 (from time zero to 48 hours postdose))
- AUC(0-8)(Cycle 1 (from time zero to 8 hours postdose))
- Css-avg(Cycle 1 (from time zero to 48 hours postdose))
- Vz(Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits)
- C48(Cycle 1 at 48 hours postdose)
- AI_AUC(Cycle 1 (Day 19, Day 15))
- AI_Cmax(Cycle 1 (Day 19, Day 15))
- T-HALFeff(Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits)
- Number of Participants With a Positive Antibody-Drug-Antibody (ADA) Response(Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits)
- Ctrough(Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits)