CTIS2023-508090-87-00进行中（未招募）1 期
A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a Single Agent and in Combination in HLA-A*02:01-Positive Participants with Selected Advanced PIWIL1-Positive Cancers
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
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
- •Age = 18 years, ECOG PS 0 or 1, HLA-A*02:01 positive, Histologically confirmed advanced colorectal, esophageal, gastric, or ovarian carcinoma, Meeting PIWIL1 testing requirements, Baseline disease evaluation / measurable based on investigator assessment, Meeting the histology, biomarker, and prior cancer treatment requirements for the applicable arm and study part, Contraception, Informed Consent
排除标准
- •Presence of untreated / symptomatic CNS metastases, leptomeningeal disease, or cord compression, Out of range laboratory values, Significant pulmonary disease or impaired lung function, Significant cardiac disease or impaired cardiac function, Specific exclusions for combination partner, Active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease, Systemic treatment with steroids or any other immunosuppressive drug use, Prior solid organ or bone marrow transplant, Uncontrolled or untreated chronic viral infection, History of malignant diseases other than those being treated in this study, Recent antibiotic use, Recent bowel obstruction, Recent use of live vaccine, Recent major surgical procedure, High risk for vital organ perforation, fistula formation, or hemorrhage, Ongoing ascites or effusion, Ongoing toxicity from prior cancer therapy, Hypersensitivity to study treatment or excipient, Inadequate washout from prior cancer treatment, Prior treatment with an ImmTAC molecule, Other contraindication for applicable combination partner
研究者
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