Status:
RECRUITING
Study of IMC-P115C in Advanced PRAME-Positive Cancers
Lead Sponsor:
Immunocore Ltd
Conditions:
PRAME Positive
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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-P...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2029
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07156136
Start Date
November 7 2024
End Date
August 30 2029
Last Update
September 4 2025
Active Locations (13)
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1
Cancer Research South Australia (CRSA)
Adelaide, Australia, 5000
2
Linear Clinical Research ltd.
Nedlands, Australia, 06009
3
Melanoma Institute Australia
Wollstonecraft, Australia, 2065
4
UNICANCER - Centre Leon-Berard (CLB)
Lyon, France, 69008