A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) targeting PRAME, as Monotherapy or in Combination with a Checkpoint Inhibitor in Patients with Recurrent and/or Refractory Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 24
- 主要终点
- Number of patients with dose-limiting toxicities (Phase I)
研究概览
简要总结
- To determine the maximum tolerated doses (MTDs) and/or recommended doses for extensions (RDEs) for IMA402 as monotherapy and in combination with pembrolizumab (Phase I) 2a) To characterize the safety and tolerability of IMA402 as monotherapy and in combination with pembrolizumab (Phase I) 2b) To characterize the safety and tolerability of IMA402 (Phase II)
- To evaluate the anti-tumor activity of IMA402 (Phase II)
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Phase II
- 盲法
- None
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
- 是
入选标准
- •Patients ≥ 18 years old
- •Pathologically confirmed and documented advanced and/or metastatic solid tumors with defined PRAME tumor target expression
- •Confirmed HLA status
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •Patients must have received or not be eligible for all available indicated standard-of-care treatments
- •Adequate baseline hematologic, renal and hepatic function, acceptable coagulation status
排除标准
- •Other active malignancies that require treatment or that might interfere with the trial endpoints
- •Patient is pregnant or is breastfeeding
- •History of hypersensitivity to components of IMA402, CPI treatment or rescue medications; contraindication for pembrolizumab
- •The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator’s or sponsor’s judgement, contraindicate the patient’s participation in the clinical trial because of safety concerns or compliance with clinical trial procedures
- •Patients with active CNS metastases
结局指标
主要结局
Number of patients with dose-limiting toxicities (Phase I)
Number of patients with dose-limiting toxicities (Phase I)
Number of patients with treatment-emergent adverse events (TEAEs) (Phase I/II)
Number of patients with treatment-emergent adverse events (TEAEs) (Phase I/II)
Number of patients with serious TEAEs (Phase I/II)
Number of patients with serious TEAEs (Phase I/II)
Frequency and duration of dose interruptions and reductions, permanent discontinuations (Phase I/II)
Frequency and duration of dose interruptions and reductions, permanent discontinuations (Phase I/II)
Objective response rate based on best overall response of complete response and partial response locally assessed using RECIST 1.1 (Phase II)
Objective response rate based on best overall response of complete response and partial response locally assessed using RECIST 1.1 (Phase II)
次要结局
未报告次要终点
研究者
Clinical Development
Scientific
Immatics Biotechnologies GmbH