CTIS2022-502684-37-00招募中1 期
A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers - IMC-F106C-101
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 277
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
- •Participant must be = 18 years of age, inclusive, at the time of signing the ICF, Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 at start of treatment, HLA-A*02:01-positive, Must meet tumor PRAME testing requirements, Relapsed from, refractory to, or intolerant of standard therapies; or in combination with standard therapies
排除标准
- •Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with treated CNS lesions may enroll provided all the following apply: a. Treated CNS lesions must be radiographically stable for = 2 weeks after intervention (surgery and/or radiation). b. Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to enrollment., Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment, Ongoing ascites or effusion requiring drainage within 28 days prior to the planned first dose of study treatment., Presence of NCI CTCAE = Grade 2 toxicity due to prior cancer therapy, Participants enrolling in pembrolizumab combination arms with prior immunotherapy exposure must not have experienced immune-mediated AE (imAE)/immune-related AE (irAE), Clinically significant pulmonary disease or impaired lung function, Clinically significant cardiac disease or impaired cardiac function, Participants with elevated risk of thrombotic/thromboembolic event
研究者
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