RecruitingPhase 1NCT07156136
Study of IMC-P115C in Advanced PRAME-Positive Cancers
A 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 Agents in HLA-A*02:01 Positive Participants With Advanced PRAME Positive Cancers
Sponsor
Immunocore Ltd
Enrollment
140 participants
Start Date
Nov 7, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria10
- 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
- Hypersensitivity to study drug or excipients
- Pregnant or lactating
Interventions
DRUGIMC-P115C
IV infusion
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07156136
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