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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Select Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT04262466

Run by

Immunocore Ltd

People needed

410

Starts

2020-02-25

Expected to finish

2027-12-01

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG PS 0 or 1
• HLA-A*02:01 positive
• PRAME positive tumor
• Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies
• If applicable, must agree to use highly effective contraception

You may not qualify if…

• Symptomatic or untreated central nervous system metastasis
• Recent bowel obstruction
• Ongoing ascites or effusion requiring recent drainages
• Significant immune-mediated adverse event with prior immunotherapy (Participants in checkpoint inhibitor combination treatment)
• Inadequate washout from prior anticancer therapy
• Significant ongoing toxicity from prior anticancer treatment
• Out-of-range laboratory values
• Clinically significant lung, heart, or autoimmune disease
• Ongoing requirement for immunosuppressive treatment
• Prior solid organ or bone marrow transplant
• Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
• Significant secondary malignancy
• Hypersensitivity to study drug or excipients
• Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
• Pregnant or lactating participants
• Any other contraindication for applicable combination partner based on local prescribing information

Where it is running

• Angeles Clinic and Research Institute — Los Angeles, California, United States
• University of California Davis Comprehensive Center — Sacramento, California, United States
• University of Colorado — Aurora, Colorado, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Houston Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan Kettering — New York, New York, United States
• University of Oklahoma Peggy and Charles Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Prisma Health — Greenville, South Carolina, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah, United States
• University of Washington - Fred Hutchinson Cancer Center — Seattle, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Scientia Clinical Research — Randwick, New South Wales, Australia
• Melanoma Institute Australia (MIA) - The Poche Centre — Wollstonecraft, New South Wales, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• University of California - San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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