NCT07195682招募中1 期
A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 281
- 试验地点
- 11
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone or in combination by participants with ccRCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.
- •For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.
- •For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other).
- •Part 3: Participants must have had at least 1 standard treatment regimen (including a PD-1/L1 checkpoint inhibitor and/or a VEGF-TKI).
- •Part 4: Participants must not have received prior systemic therapy for metastatic RCC, but may have received prior adjuvant therapy for completely resected RCC with PD-1 inhibitor if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
- •Eastern Cooperative Oncology Group performance status of 0 to 1.
排除标准
- •Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.
- •Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.
- •Part 2A and Part 4: Participants who have received prior treatment with belzutifan (or another HIF2a inhibitor).
- •Part 3B and Part 4B: Participants who have received prior ipilimumab (or another anti-CTLA-4 containing antibody).
- •Participants who have hypoxia as defined by a pulse oximeter reading < 92% at rest or requires intermittent or chronic supplemental oxygen.
- •Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.
- •Part 3 and Part 4: Participants with a history of Grade ≥3 immune-mediated AEs leading to discontinuation of prior immunotherapy.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part 1A BMS-986506 Monotherapy Escalation
Experimental
干预措施: BMS-986506 (Drug)
Part 2A BMS-986506 Monotherapy Expansion
Experimental
干预措施: BMS-986506 (Drug)
Part 2B BMS-986506 Monotherapy Expansion
Experimental
干预措施: BMS-986506 (Drug)
Part 3A BMS-986506 + Pumitamig Combination Dose Escalation
Experimental
干预措施: BMS-986506 (Drug)
Part 3A BMS-986506 + Pumitamig Combination Dose Escalation
Experimental
干预措施: Pumitamig (Drug)
Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation
Experimental
干预措施: BMS-986506 (Drug)
Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation
Experimental
干预措施: Pumitamig (Drug)
Part 4A BMS-986506 + Pumitamig Combination Dose Expansion
Experimental
干预措施: BMS-986506 (Drug)
Part 4A BMS-986506 + Pumitamig Combination Dose Expansion
Experimental
干预措施: Pumitamig (Drug)
Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion
Experimental
干预措施: BMS-986506 (Drug)
Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion
Experimental
干预措施: Pumitamig (Drug)
Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation
Experimental
干预措施: Ipilimumab (Drug)
Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion
Experimental
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria
时间窗: Up to approximately Day 28
Number of Participants With AEs Leading to Discontinuation
时间窗: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0
时间窗: Up to approximately 2 years from first dose of BMS-986506
次要结局
- Maximum Observed Plasma Concentration (Cmax) of BMS-986506(Up to approximately Day 85)
- Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506(Up to approximately Day 112)
- Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506(Up to approximately Day 112)
- Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)(Up to approximately 3 years from first dose of BMS-986506)
- Disease Control Rate (DCR) as Assessed by RECIST v1.1(Up to approximately 3 years from first dose of BMS-986506)
- Duration of Response (DOR) as Assessed by RECIST v1.1(Up to approximately 3 years from first dose of BMS-986506)
- Time to Response (TTR) as Assessed by RECIST v1.1(Up to approximately 3 years from first dose of BMS-986506)
研究者
研究点 (11)
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