Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
NCT ID: NCT04262466
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
727 participants
INTERVENTIONAL
2020-02-25
2026-08-31
Brief Summary
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Detailed Description
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1. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose (RP2D) of brenetafusp as a single agent and administered in combination with chemotherapies, targeted therapies, and monoclonal antibodies.
2. Phase 2: To assess the efficacy of brenetafusp in selected advanced solid tumors.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Brenetafusp Monotherapy
Participants receive brenetafusp.
Brenetafusp
Brenetafusp IV infusions
Brenetafusp and Anti-PD(L)1 Agent
Participants receive brenetafusp and pembrolizumab.
Brenetafusp and pembrolizumab
Brenetafusp and pembrolizumab IV infusions
Brenetafusp and Chemotherapy
Participants receive brenetafusp and chemotherapy. Choice of chemotherapy is dependent on cohort.
Brenetafusp and chemotherapy
Brenetafusp and chemotherapy IV infusions
Brenetafusp and Targeted Therapy
Participants receive brenetafusp and a selected targeted therapy. Receipt of kinase inhibitor is dependent on histology.
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
Brenetafusp and Multimodal Therapy
Participants receive brenetafusp, biologics (eg, pembrolizumab, bevacizumab) IV infusions and chemotherapy IV infusions based on histology.
Brenetafusp and monoclonal antibodies and chemotherapy
Brenetafusp and a monoclonal antibody therapy and chemotherapy
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Immunocore Ltd
INDUSTRY
Responsible Party
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Locations
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University of California - San Diego
La Jolla, California, United States
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
Linear Clinical Research
Nedlands, Western Australia, Australia
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, , Austria
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium
CHU de Liege
Liège, Luik, Belgium
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, Canada
CHUM Centre de Recherche
Montreal, Quebec, Canada
Institut Bergonie - Nouvelle-Aquitaine
Bordeaux, Gironde, France
Gustave Roussy (Institut de Cancerologie Gustave-Roussy)
Villejuif, Val De Marne, France
Universite Claude Bernard Lyon Est
Lyon, Villeurbanne, France
Hopital Saint-Louis - Centre d'Onco-Dermatologie
Paris, , France
Institut Curie
Paris, , France
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
St Vincents University Hospital
Dublin, , Ireland
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche
Rome, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Patologia Ostetrica e Ginecologica
Seriate, Roma, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
Napoli, , Italy
Netherlands Cancer Institute
Amsterdam, CX, Netherlands
UMC Groningen Comprehensive Cancer Center
Groningen, GZ, Netherlands
Leiden UMC
Leiden, ZA, Netherlands
New Zealand Clinical Research-Auckland
Auckland, , New Zealand
Centrum Medyczne Pratia Poznan - Skorzewo
Skórzewo, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, , Poland
Seoul National University Hospital
Seoul, , South Korea
Yonsei University College of Medicine
Seoul, , South Korea
University of Ulsan College of Medicine
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
Pamplona, Navarre, Spain
NEXT Barcelona
Barcelona, , Spain
Hospital Universitario Vall dHebron
Barcelona, , Spain
Hospital Duran i Reynals
Barcelona, , Spain
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
University Hospital, Basel Switzerland
Basel, , Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, , Switzerland
University Hospital of Zurich
Zurich, , Switzerland
Sarah Cannon Research Institute UK
London, City of London, United Kingdom
University of Oxford
Oxford, Oxfordshire, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
University of Liverpool
Liverpool, , United Kingdom
University College Hospital London
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Royal Marsden Hospital
Surrey Quays, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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IMC-F106C-101
Identifier Type: -
Identifier Source: org_study_id
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