2023-503651-10-00招募中2 期
A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants with Advanced Solid Tumors
Bristol-Myers Squibb Services Unlimited Company17 个研究点 分布在 3 个国家目标入组 163 人开始时间: 2023年8月11日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 163
- 试验地点
- 17
- 主要终点
- Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death
研究概览
简要总结
To assess the safety, tolerability, and to determine the MTD, MAD, and/or RP2D(s) of BMS-986340 administered as monotherapy and in combination with nivolumab or docetaxel
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Radiographically documented progressive disease on or after the most recent therapy
- •Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded)
- •Participants must have advanced or metastatic disease, and have received, be refractory to, not be a candidate for, or be intolerant to existing therapies known to provide clinical benefit for the condition of the participant. Eligible tumor types for each Part are listed below: - Parts 1A and 1B: NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, cervical cancer (SCC or adenocarcinoma), RCC, UC, PDAC, melanoma, OC, or TNBC. - Parts 2A and 2B: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, or up to 3 additional tumor types from Parts 1A and 1B may be considered based on emerging data. - Part 1C: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, OC, or TNBC. Other protocol-defined inclusion criteria apply.
排除标准
- •Women who are pregnant or breastfeeding
- •Major surgery within 4 weeks of study drug administration
- •History of or with active interstitial lung disease or pulmonary fibrosis Other protocol-defined exclusion criteria apply
- •Primary central nervous system (CNS) malignancy
- •Untreated CNS metastases
- •Leptomeningeal metastases
- •Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
- •Active, known, or suspected autoimmune disease
- •Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
- •Prior organ or tissue allograft
- •Uncontrolled or significant cardiovascular disease
结局指标
主要结局
Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death
Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death
次要结局
- Summary measures of PK parameters of BMS-986340 administered as monotherapy and in combination with nivolumab or docetaxel
- Incidence of anti-drug antibodies to BMS-986340 when BMS-986340 is administered as monotherapy and in combination with nivolumab or docetaxel
- ORR, DCR, DOR, and PFSR
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (17)
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