NCT07156136招募中1 期
A Phase 1 First-in-Human Study of the Safety and Efficacy of IMC-P115C as a Single Agent and in Combination With Standard of Care Agents in HLA-A*02:01 Positive Participants With Advanced PRAME Positive Cancers
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
- 140
- 试验地点
- 13
- 主要终点
- Percentage of participants with dose-limiting toxicities (DLT)
研究概览
简要总结
Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •HLA-A*02:01-positive
- •Meeting PRAME-positive tumor testing requirements
- •Metastatic or unresectable solid tumors
- •Have received (or be receiving), relapsed from, be refractory to or intolerant of all therapies
- •Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control
排除标准
- •Symptomatic or untreated central nervous system metastasis
- •Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment
- •Ongoing ascites or effusion requiring recent drainages
- •Significant ongoing toxicity from prior anticancer treatment
- •Out-of-range laboratory values
- •Clinically significant lung, heart, or autoimmune disease
- •Ongoing requirement for immunosuppressive treatment
- •Significant secondary malignancy
- •Hypersensitivity to study drug or excipients
- •Pregnant or lactating
研究组 & 干预措施
Arm A: IMC-P115C Monotherapy
Experimental
Participants receive IMC-P115C intravenous (IV) infusion
干预措施: IMC-P115C (Drug)
结局指标
主要结局
Percentage of participants with dose-limiting toxicities (DLT)
时间窗: Up to ~16 months
Percentage of participants with adverse events (AE)
时间窗: Up to ~16 months
Percentage of participants with serious adverse events (SAE)
时间窗: Up to ~16 months
Percentage of participants with a dose interruption, reduction, or discontinuation
时间窗: Up to ~16 months
Percentage of participants with dosing changes or discontinuations.
次要结局
- Best Overall Response (BOR) as determined by RECIST v1.1 per the Investigator.(Up to ~19 months)
- Duration of Response (DOR) as determined by RECIST v1.1 per the Investigator.(Up to ~19 months)
- Progression Free Survival (PFS) as determined by RECIST v1.1 per the Investigator.(Up to ~19 months)
- Overall Survival (OS)(Up to ~19 months)
- Change from baseline in lymphocyte counts(Up to ~19 months)
- Changes in serum cytokine concentrations(Up to ~19 months)
- IMC-P115C Plasma Concentration(Up to ~19 months)
- Percentage of participants with anti-IMC-P115C antibody formation(Up to ~19 months)
研究者
研究点 (13)
Loading locations...
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