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

Study Identifier:
IMC-P115C-1005
CT.gov Identifier:
NCT07156136
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-509767-25-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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.

A clinical study of IMC-P115C in patients with multiple solid Tumors.

To assess the safety and clinical activity of IMC-P115C in HLA-A*02:01-positive patients with advanced solid tumors that express PRAME

To evaluate the safety, pharmacokinetics and clinical activity of IMC-P115C in HLA-A*02:01-positive patients with a range of advanced cancers expressing PRAME.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Biomarkers
  • Unspecified Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Arm A
    • Read More
  • Drug: Patients treated with IMC-P115C.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Biomarkers
    Unspecified Cancer