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Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
Trial Status: active
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.
Inclusion Criteria
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
Exclusion Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT04262466.
Locations matching your search criteria
United States
California
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not Available
Sacramento
University of California Davis Comprehensive Cancer Center
