EUCTR2021-001188-26-DE进行中（未招募）1 期
A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants with Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 277
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 167
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •Women who are pregnant or breastfeeding
- •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
- •Major surgery within 4 weeks of study drug administration
- •History of or with active interstitial lung disease or pulmonary fibrosis
- •Other protocol-defined inclusion/exclusion criteria apply
研究者
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