RECRUITING

Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors

Description

Brenetafusp (IMC-F106C) is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of brenetafusp in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.

Conditions

Select Advanced Solid Tumors
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Related Conditions:

Select Advanced Solid Tumors

Study Overview

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Study Details

Study overview

Brenetafusp (IMC-F106C) is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of brenetafusp in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.

Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers

Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors

Condition
Select Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

La Jolla

University of California - San Diego, La Jolla, California, United States, 92093

Los Angeles

Angeles Clinic and Research Institute, Los Angeles, California, United States, 90025

Sacramento

University of California Davis Comprehensive Center, Sacramento, California, United States, 95817

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Washington

Georgetown University Medical Center, Washington, District of Columbia, United States, 20057

Tampa

Houston Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States, 33612

Chicago

The University of Chicago Medical Center, Chicago, Illinois, United States, 60637

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Hackensack

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. ECOG PS 0 or 1
  • 2. HLA-A\*02:01 positive
  • 3. PRAME positive tumor
  • 4. Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies
  • 5. If applicable, must agree to use highly effective contraception
  • 1. Symptomatic or untreated central nervous system metastasis
  • 2. Recent bowel obstruction
  • 3. Ongoing ascites or effusion requiring recent drainages
  • 4. Significant immune-mediated adverse event with prior immunotherapy (patients in checkpoint inhibitor combination treatment)
  • 5. Inadequate washout from prior anticancer therapy
  • 6. Significant ongoing toxicity from prior anticancer treatment
  • 7. Out-of-range laboratory values
  • 8. Clinically significant lung, heart, or autoimmune disease
  • 9. Ongoing requirement for immunosuppressive treatment
  • 10. Prior solid organ or bone marrow transplant
  • 11. Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
  • 12. Significant secondary malignancy
  • 13. Hypersensitivity to study drug or excipients
  • 14. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
  • 15. Pregnant or lactating
  • 16. Any other contraindication for applicable combination partner based on local prescribing information

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Immunocore Ltd,

Study Record Dates

2026-08