RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 participants who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.

Official Title

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

Quick Facts

Study Start:2020-02-25
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04262466

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ECOG PS 0 or 1
  2. 2. HLA-A\*02:01 positive
  3. 3. PRAME positive tumor
  4. 4. Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies
  5. 5. If applicable, must agree to use highly effective contraception
  1. 1. Symptomatic or untreated central nervous system metastasis
  2. 2. Recent bowel obstruction
  3. 3. Ongoing ascites or effusion requiring recent drainages
  4. 4. Significant immune-mediated adverse event with prior immunotherapy (Participants in checkpoint inhibitor combination treatment)
  5. 5. Inadequate washout from prior anticancer therapy
  6. 6. Significant ongoing toxicity from prior anticancer treatment
  7. 7. Out-of-range laboratory values
  8. 8. Clinically significant lung, heart, or autoimmune disease
  9. 9. Ongoing requirement for immunosuppressive treatment
  10. 10. Prior solid organ or bone marrow transplant
  11. 11. Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
  12. 12. Significant secondary malignancy
  13. 13. Hypersensitivity to study drug or excipients
  14. 14. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
  15. 15. Pregnant or lactating participants
  16. 16. Any other contraindication for applicable combination partner based on local prescribing information

Contacts and Locations

Study Contact

Immunocore Medical Information
CONTACT
844-466-8661
medical.information@immunocore.com
Immunocore Medical Information EU
CONTACT
+00 800-744-51111
medinfo.eu@immunocore.com

Study Locations (Sites)

University of California - San Diego
La Jolla, California, 92093
United States
Angeles Clinic and Research Institute
Los Angeles, California, 90025
United States
University of California Davis Comprehensive Center
Sacramento, California, 95817
United States
University of Colorado
Aurora, Colorado, 80045
United States
Georgetown University Medical Center
Washington, District of Columbia, 20057
United States
Houston Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
United States
The University of Chicago Medical Center
Chicago, Illinois, 60637
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering
New York, New York, 10065
United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Prisma Health
Greenville, South Carolina, 92697
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
University of Washington - Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Immunocore Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-25
Study Completion Date2026-08

Study Record Updates

Study Start Date2020-02-25
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • Select Advanced Solid Tumors