NCT05298592进行中（未招募）1 期
A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Malignant Tumors
Bristol-Myers Squibb29 个研究点 分布在 6 个国家目标入组 154 人开始时间: 2022年3月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
- 试验地点
- 29
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.
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
- •Parts 1A, 1B, 1C:
- •Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.
- •Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Adequate organ function
排除标准
- •Prior organ or tissue allograft
- •Leptomeningeal metastases
- •Untreated CNS metastases
- •Serious or uncontrolled medical disorders
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel
Experimental
干预措施: Pemetrexed (Drug)
Part 1A: BMS-986406 (Monotherapy Dose Escalation)
Experimental
干预措施: BMS-986406 (Biological)
Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)
Experimental
干预措施: BMS-986406 (Biological)
Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)
Experimental
干预措施: Nivolumab (Biological)
Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)
Experimental
干预措施: BMS-986406 (Biological)
Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)
Experimental
干预措施: Nivolumab (Biological)
Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)
Experimental
干预措施: BMS-986406 (Biological)
Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)
Experimental
干预措施: Nivolumab (Biological)
Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel
Experimental
干预措施: BMS-986406 (Biological)
Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel
Experimental
干预措施: Nivolumab (Biological)
Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel
Experimental
干预措施: Carboplatin (Drug)
Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to 100 days
Number of participants with serious adverse events (SAEs)
时间窗: Up to 100 days
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
时间窗: Up to 28 days
Number of participants with AEs leading to discontinuation
时间窗: Up to 100 days
Number of participants with death
时间窗: Up to 100 days
次要结局
- Maximum observed plasma concentration (Cmax)(Up to 14 days)
- Time of maximum observed plasma concentration (Tmax)(Up to 14 days)
- Trough observed plasma concentration (Ctrough)(Up to 14 days)
- Incidence of anti-drug antibody (ADAs)(Up to 14 days)
- Objective response rate (ORR)(Up to 24 months)
- Disease control rate (DCR)(Up to 24 months)
- Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma(Up to 24 months)
- DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer(Up to 24 months)
- DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types(Up to 24 months)
研究者
研究点 (29)
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