2025-523547-35-00招募中2 期
A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Malignancies
Bristol-Myers Squibb Services Unlimited Company2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2026年5月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- How often side effects occur, including serious ones, side effects that meet study rules for a dose-limiting toxicity, and side effects that make people stop study treatment or cause death.
研究概览
简要总结
To find out if BMS-986523 is safe and tolerable and to figure out the best dose and schedule for using BMS-986523 alone or with pembrolizumab, cetuximab, or gemcitabine plus nab-paclitaxel in participants with advanced solid malignancies that have KRAS alterations.
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
- 否
入选标准
- •Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known KRAS alteration (mutation or amplification): Part 1A: All tumor types (Arms A and B); Part 2A: NSCLC, CRC, and PDAC (Arm C); Part 1B: NSCLC (Arm D), CRC (Arm E), and PDAC (Arm F).
- •Participants should have previously received, be ineligible for, or declined (after having been provided adequate information to make an informed decision) select standard of care treatments depending on their assigned study arm.
排除标准
- •Untreated central nervous system (CNS) metastases.
- •Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
- •Prior treatment with a (K)RAS directed therapy including approved treatments and investigational agents.
研究组 & 干预措施
BMS-986523, BMS-986523
Test
干预措施: BMS-986523 (Drug)
结局指标
主要结局
How often side effects occur, including serious ones, side effects that meet study rules for a dose-limiting toxicity, and side effects that make people stop study treatment or cause death.
How often side effects occur, including serious ones, side effects that meet study rules for a dose-limiting toxicity, and side effects that make people stop study treatment or cause death.
次要结局
- Overall response rate to BMS-986523 and how long that response lasts based on RECIST v1.1 as judged by the study doctor.
- How BMS-986523 moves through and is processed by the body, including the highest level of the drug in the blood (Cmax), how long it takes to reach that level (Tmax), and overall exposure (AUC), based on blood tests over time.
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (2)
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