CTIS2022-503133-54-00招募中1 期
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, in Patients with Recurrent and/or Refractory Solid Tumors - IMA402-101
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 155
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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 or rescue medications, The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator’s judgement, contraindicate the patient’s participation in the clinical trial because of safety concerns or compliance with clinical trial procedures, Patients with active brain metastases
研究者
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