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Recruiting Phase 1 NCT07156136

Study of IMC-P115C in Advanced PRAME-Positive Cancers

Phase 1 – testing safety in a small group of people
Conditions: PRAME Positive Cancer HLA-A*02:01-positive

Sponsor: Immunocore Ltd

trial.available_in: БГ
Overview
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.
Who can participate
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 * Hypersensitivity to study drug or excipients * Pregnant or lactating
Locations 4
Australia (1)
Cancer Research South Australia (CRSA)
Adelaide
France (1)
UNICANCER - Centre Leon-Berard (CLB)
Lyon
Italy (1)
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan
Spain (1)
Hospital Universitari Vall d Hebron
Barcelona
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.11.2024
Completion date
30.08.2029
Registry ID
NCT07156136
Source
anzctr
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