NCT05888831进行中（未招募）1 期
A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Bristol-Myers Squibb20 个研究点 分布在 6 个国家目标入组 100 人开始时间: 2023年6月6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
- 100
- 试验地点
- 20
- 主要终点
- Number of participants with Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.
- •Part 1A may have a solid malignancy of any histology.
- •Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
- •Part 1C is restricted to participants with Triple-negative breast cancer (TNBC).
- •Tumor biopsy must be obtained for all participants (unless medically precluded).
排除标准
- •History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or anti-PD- 1/programmed death-ligand 1 [PD-L1] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures.
- •Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention.
- •Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
- •Other protocol-defined criteria may apply.
研究组 & 干预措施
Dose Escalation: BMS-986449 + nivolumab
Experimental
干预措施: BMS-986449 (Drug)
Dose Escalation: BMS-986449 monotherapy
Experimental
干预措施: BMS-986449 (Drug)
Dose Escalation: BMS-986449 + nivolumab
Experimental
干预措施: Nivolumab (Drug)
Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts
Experimental
干预措施: BMS-986449 (Drug)
结局指标
主要结局
Number of participants with Dose-Limiting Toxicities (DLTs)
时间窗: Up to approximately 4 years
Number of participants with AEs leading to discontinuation
时间窗: Up to approximately 4 years
Number of participants with Adverse Events (AEs)
时间窗: Up to approximately 4 years
Number of participants with Serious Adverse Events (SAEs)
时间窗: Up to approximately 4 years
Number of deaths
时间窗: Up to approximately 4 years
次要结局
- Time of maximum observed concentration within a dosing interval (Tmax)(Up to approximately 4 years)
- Area under the concentration-time curve within a dosing interval (AUC[TAU])(Up to approximately 4 years)
- Maximum observed plasma concentration (Cmax)(Up to approximately 4 years)
研究者
研究点 (20)
Loading locations...
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