Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers

Last updated: February 17, 2025
Sponsor: Immunocore Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cancer

Treatment

IMC-R117C

Kinase inhibitor

Antiangiogenic Agent

Clinical Study ID

NCT06840119
IMC-R117C-1004
2023-508090-87-00
  • Ages > 18
  • All Genders

Study Summary

This phase 1/2 first-in-human study is designed to test the safety and efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a single agent and in combination with other therapies in HLA-A*02:01-positive participants with selected advanced cancers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

  • HLA-A*02:01-positive

  • Histologically confirmed advanced colorectal, esophageal, gastric, or ovariancarcinoma

  • Archived or fresh tumor tissue sample that must be confirmed as adequate

  • Evaluable/Measurable disease per RECIST 1.1

  • Previously received applicable standard treatments

  • Male and female participants of childbearing potential who are sexually active witha non-sterilized partner must agree to use highly effective methods of birth control

Exclusion

Exclusion Criteria:

  • Symptomatic or untreated central nervous system metastasis

  • Recent bowel obstruction

  • 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

Study Design

Total Participants: 600
Treatment Group(s): 5
Primary Treatment: IMC-R117C
Phase: 1/2
Study Start date:
January 10, 2024
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Peter MacCallum Cancer Centre

    Melbourne,
    Australia

    Active - Recruiting

  • Institut Jules Bordet

    Anderlecht, 1070
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent,
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Antoni van Leeuwenhoek

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Hospital HM Nou Delfos

    Barcelona,
    Spain

    Active - Recruiting

  • Centro Integral Oncologico Clara Campal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid,
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.