NCT06730750进行中（未招募）1 期
A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
Bristol-Myers Squibb18 个研究点 分布在 3 个国家目标入组 360 人开始时间: 2025年2月12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
- 360
- 试验地点
- 18
- 主要终点
- Number of participnats with Adverse Events (AEs)
研究概览
简要总结
This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.
- •CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:
- •i) Locally advanced/metastatic, recurrent, or unresectable CRC with adenocarcinoma histology and whose disease has progressed after systemic cancer therapy in the metastatic or adjuvant setting including 5-FU, irinotecan, and/or oxaliplatin (if available and not contraindicated).
- •NSCLC: Part 2A-NSCLC/GC, 2L+ NSCLC:
- •i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.
- •ii) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.
- •- GC: Part 2A-NSCLC/GC, 2L+ GC: i) Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy).
- •ii) ECOG performance status of 0 or 1.
排除标准
- •History of anaphylactic reactions to irinotecan and/or bevacizumab.
- •Previously received therapy targeting CEACAM
- •Grade ≥3 ILD/pneumonitis.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC)
Experimental
干预措施: BMS-986490 (Drug)
Part 1B
Experimental
干预措施: BMS-986490 (Drug)
Part 2B
Experimental
干预措施: BMS-986490 (Drug)
Part 1A
Experimental
干预措施: BMS-986490 (Drug)
Part 1B
Experimental
干预措施: Bevacizumab (Drug)
Part 2B
Experimental
干预措施: Bevacizumab (Drug)
Part 2A - Colorectal Cancer (CRC)
Experimental
干预措施: BMS-986490 (Drug)
结局指标
主要结局
Number of participnats with Adverse Events (AEs)
时间窗: Up to 100 days following discontinuation of dosing
Number of participants with Serious AEs (SAEs)
时间窗: Up to 100 days following discontinuation of dosing
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
时间窗: Up to 28 days after the first treatment of study intervention
Number of participants with AEs leading to discontinuation
时间窗: Up to 100 days following discontinuation of dosing
Number of deaths
时间窗: Up to 100 days following discontinuation of dosing
次要结局
- Area under the concentration-time curve in 1 dosing interval (AUC(TAU))(Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days))
- Trough observed concentration (Ctrough)(Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days))
- Maximum observed concentration (Cmax)(Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days))
- Time of maximum observed concentration (Tmax)(Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days))
- Total anti-drug antibodies (ADAs)(Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days))
- Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by Investigator(Up to approximately 4 years)
研究者
研究点 (18)
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