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

Last updated: April 28, 2025
Sponsor: Immunocore Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Brenetafusp

Brenetafusp and monoclonal antibodies and chemotherapy

Brenetafusp and chemotherapy

Clinical Study ID

NCT04262466
IMC-F106C-101
  • Ages > 18
  • All Genders

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

Eligibility Criteria

Inclusion

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, incombination with standard therapies

  5. If applicable, must agree to use highly effective contraception

Exclusion

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 (patients incheckpoint 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 immunodeficiencyvirus (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 studyintervention

  15. Pregnant or lactating

  16. Any other contraindication for applicable combination partner based on localprescribing information

Study Design

Total Participants: 727
Treatment Group(s): 15
Primary Treatment: Brenetafusp
Phase: 1/2
Study Start date:
February 25, 2020
Estimated Completion Date:
August 31, 2026

Study Description

The IMC-F106C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases.

  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.

Connect with a study center

  • Scientia Clinical Research

    Randwick, New South Wales 2031
    Australia

    Completed

  • Melanoma Institute Australia (MIA) - The Poche Centre

    Wollstonecraft, New South Wales 2065
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020
    Austria

    Completed

  • Universitair Ziekenhuis Brussel

    Jette, Brussel 1090
    Belgium

    Active - Recruiting

  • CHU de Liege

    Liège, Luik 4000
    Belgium

    Active - Recruiting

  • Institut Jules Bordet

    Bruxelles, 1070
    Belgium

    Active - Recruiting

  • UZA

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, 91350-200
    Brazil

    Active - Recruiting

  • National Cancer Institute

    Rio De Janeiro,
    Brazil

    Active - Recruiting

  • D'Or Institute for Research and Education

    Rio de Janeiro,
    Brazil

    Active - Recruiting

  • Hospital Israelita Albert Einstein

    São Paulo,
    Brazil

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • CHUM Centre de Recherche

    Montréal, Quebec H2X 0A9
    Canada

    Completed

  • Institut Bergonie - Nouvelle-Aquitaine

    Bordeaux, Gironde
    France

    Active - Recruiting

  • Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

    Villejuif, Val De Marne 94805
    France

    Active - Recruiting

  • Institute Gustave Roussy

    Villejuif, Val De Marne 94805
    France

    Active - Recruiting

  • Universite Claude Bernard Lyon Est

    Lyon, Villeurbanne 69100
    France

    Active - Recruiting

  • Hopital Saint-Louis - Centre d'Onco-Dermatologie

    Paris, 75010
    France

    Active - Recruiting

  • Institut Curie

    Paris,
    France

    Active - Recruiting

  • L'Hopital St. Louis

    Paris, 75010
    France

    Active - Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Completed

  • St Vincents University Hospital

    Dublin,
    Ireland

    Completed

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche

    Rome, Roma 00168
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Patologia Ostetrica e Ginecologica

    Seriate, Roma 00168
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale

    Napoli, 80131
    Italy

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • University of Ulsan College of Medicine

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Yonsei University College of Medicine

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Netherlands Cancer Institute

    Amsterdam, CX 1066
    Netherlands

    Active - Recruiting

  • UMC Groningen Comprehensive Cancer Center

    Groningen, GZ 9713
    Netherlands

    Active - Recruiting

  • Leiden UMC

    Leiden, ZA 2333
    Netherlands

    Active - Recruiting

  • New Zealand Clinical Research-Auckland

    Auckland, 92697
    New Zealand

    Active - Recruiting

  • Centrum Medyczne Pratia Poznan - Skorzewo

    Skórzewo, 60-185
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warszawa, 02-781
    Poland

    Active - Recruiting

  • Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital Duran i Reynals

    Barcelona, 08908
    Spain

    Active - Recruiting

  • Hospital Universitario Vall dHebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • NEXT Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid

    Madrid, 28022
    Spain

    Active - Recruiting

  • University Hospital, Basel Switzerland

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Centre Hospitalier Universitaire Vaudois Lausanne

    Lausanne,
    Switzerland

    Active - Recruiting

  • University Hospital of Zurich

    Zürich, 8058
    Switzerland

    Completed

  • Sarah Cannon Research Institute UK

    London, City Of London W1G6AD
    United Kingdom

    Active - Recruiting

  • University of Oxford

    Oxford, Oxfordshire OX3 7LI
    United Kingdom

    Active - Recruiting

  • The Beatson West of Scotland Cancer Centre

    Glasgow, Scotland G12 0YN
    United Kingdom

    Active - Recruiting

  • University of Liverpool

    Liverpool, L69 3BX
    United Kingdom

    Active - Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • University College Hospital London

    London, W1T7HA
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust

    Manchester,
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital

    Surrey Quays, SM25PT
    United Kingdom

    Active - Recruiting

  • Honor Health

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • University of California Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • University of California - San Diego

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Angeles Clinic and Research Institute

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • University of California Davis Comprehensive Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California - San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Georgetown University Medical Center

    Washington, District of Columbia 20057
    United States

    Active - Recruiting

  • Lombardi Comprehensive Cancer Center

    Washington, District of Columbia 20057
    United States

    Site Not Available

  • Houston Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Winship Cancer Institute of Emory university

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • The University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Memorial Sloan Kettering

    New York, New York 10065
    United States

    Active - Recruiting

  • University of Oklahoma Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Prisma Health

    Greenville, South Carolina 92697
    United States

    Completed

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • University of Washington - Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

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