NCT07156136 Study of IMC-P115C in Advanced PRAME-Positive Cancers
| NCT ID | NCT07156136 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Immunocore Ltd |
| Condition | PRAME Positive |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-11-07 |
| Primary Completion | 2027-09-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.
Eligibility Criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * HLA-A\*02:01-positive * Meeting PRAME-positive tumor testing requirements * Metastatic or unresectable solid tumors * Have received (or be receiving), relapsed from, be refractory to or intolerant of all therapies * Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control Exclusion Criteria: * Symptomatic or untreated central nervous system metastasis * Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment * Ongoing ascites or effusion requiring recent drainages * Significant ongoing toxicity from prior anticancer treatment * Out-of-range laboratory values * Clinically significant lung, heart, or autoimmune disease * Ongoing requirement for immunosuppressive treatment * Significant secondary malignancy * Hyperse