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

NCT04262466 · tracked via the Priya Life Science Italy tracker

Sponsor

Immunocore Ltd

Phase

Phase 1/2

Started

2020-02-25

Last updated

2026-03-06

Condition(s) studied

Select Advanced Solid Tumors

Investigational drug(s) / intervention(s)

Brenetafusp →Brenetafusp and pembrolizumabBrenetafusp and chemotherapyBrenetafusp and monoclonal antibodies and chemotherapyBrenetafusp and tebentafuspBrenetafusp and bevacizumabBrenetafusp and kinase inhibitors

Brenetafusp: Brenetafusp IV infusions

Brenetafusp and pembrolizumab: Brenetafusp and pembrolizumab IV infusions

Brenetafusp and chemotherapy: Brenetafusp and chemotherapy IV infusions

Brenetafusp and monoclonal antibodies and chemotherapy: Brenetafusp and a monoclonal antibody therapy and chemotherapy

Brenetafusp and tebentafusp: Brenetafusp and tebentafusp IV infusions

Brenetafusp and bevacizumab: Brenetafusp and bevacizumab IV infusions

Brenetafusp and kinase inhibitors: Brenetafusp and oral kinase inhibitors

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion 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 Exclusion Criteria: 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 (Participants 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 participants 16. Any other contraindication for applicable combination partner based on local prescribing information

Primary outcome measure(s)

Phase 1: Incidence of dose-limiting toxicity (DLT)s — Up to ~28 days after each dose
Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE) — Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations — Up to ~12 months
Phase 1: Number of participants with abnormal laboratory test results (hematology) — Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal laboratory test results (chemistry) — Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal laboratory test results (coagulation) — Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal urinalysis — Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal vital signs — Up to 30 days after the last dose of study therapy
Phase 1: Mean change from baseline in QTcF interval — Up to 30 days after the last dose of study therapy
Phase 2: Best overall response (BOR) — Up to ~2 years

Trial sites (76)

Facility	City	Region
University of California - San Diego	La Jolla	California
Angeles Clinic and Research Institute	Los Angeles	California
University of California Davis Comprehensive Center	Sacramento	California
University of Colorado	Aurora	Colorado
Georgetown University Medical Center	Washington D.C.	District of Columbia
Houston Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
The University of Chicago Medical Center	Chicago	Illinois
University of Iowa	Iowa City	Iowa
Massachusetts General Hospital	Boston	Massachusetts
John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
Columbia University Medical Center	New York	New York
Memorial Sloan Kettering	New York	New York
University of Oklahoma Peggy and Charles Stephenson Cancer Center	Oklahoma City	Oklahoma
Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
Prisma Health	Greenville	South Carolina
Sarah Cannon Research Institute	Nashville	Tennessee
MD Anderson Cancer Center	Houston	Texas
University of Utah - Huntsman Cancer Institute	Salt Lake City	Utah
University of Washington - Fred Hutchinson Cancer Center	Seattle	Washington
University of Wisconsin	Madison	Wisconsin
Scientia Clinical Research	Randwick	New South Wales
Melanoma Institute Australia (MIA) - The Poche Centre	Wollstonecraft	New South Wales
The Alfred Hospital	Melbourne	Victoria
Linear Clinical Research	Nedlands	Western Australia
LKH - Universitätsklinikum der PMU Salzburg	Salzburg	Austria
Universitair Ziekenhuis Brussel	Jette	Brussels Capital
CHU de Liege	Liège	Luik
Institut Jules Bordet	Brussels	Belgium
UZA	Edegem	Belgium
Universitair Ziekenhuis Gent	Ghent	Belgium
UZ Leuven	Leuven	Belgium
Hospital Nossa Senhora da Conceicao	Porto Alegre	Brazil
D'Or Institute for Research and Education	Rio de Janeiro	Brazil
National Cancer Institute	Rio de Janeiro	Brazil
Hospital Israelita Albert Einstein	São Paulo	Brazil
Princess Margaret Cancer Centre	Toronto	Ontario
CHUM Centre de Recherche	Montreal	Quebec
Institut Bergonie - Nouvelle-Aquitaine	Bordeaux	Gironde

+ 36 more sites — see the full list on the official registry below.

More Immunocore Ltd trials in Italy

Study of IMC-P115C in Advanced PRAME-Positive Cancers Recruiting

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) Recruiting

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

Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) Recruiting

Other trials for the same condition

First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04262466 on ClinicalTrials.gov ↗ ← All trials in Italy