Phase 1/2 Study of IMC-R117C in Selected Advanced PIWIL1 Positive Cancers
- Conditions
- Advanced cancers that are PIWIL1-positiveMedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508090-87-00
- Lead Sponsor
- Immunocore Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 55
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method