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

NCT04262466 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: IMC-F106C-101
• Study Type: interventional
• Target: 410
• Locations: 16 countries
• Sites: 75

Brief 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.

Conditions

Select Advanced Solid Tumors

Outcome Measures

Primary Outcomes (10)

• 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

Secondary Outcomes (12)

• Phase I: Best Overall Response (BOR)

  Up to ~2 years

• Progression-free survival (PFS)

  Up to ~2 years

• Duration of response (DOR)

  Up to ~2 years

• Overall survival

  Up to ~2 years

• Area under the plasma concentration-time curve (AUC) of brenetafusp

  At designated time points up to ~3 weeks

Study Arms (5)

Brenetafusp Monotherapy

EXPERIMENTAL

Participants receive brenetafusp.

Drug: Brenetafusp

Brenetafusp and Anti-PD(L)1 Agent

EXPERIMENTAL

Participants receive brenetafusp and pembrolizumab.

Drug: Brenetafusp and pembrolizumab

Brenetafusp and Chemotherapy

EXPERIMENTAL

Participants receive brenetafusp and chemotherapy. Choice of chemotherapy is dependent on cohort.

Drug: Brenetafusp and chemotherapy

Brenetafusp and Targeted Therapy

EXPERIMENTAL

Participants receive brenetafusp and a selected targeted therapy. Receipt of kinase inhibitor is dependent on histology.

Drug: Brenetafusp and tebentafusp; Drug: Brenetafusp and bevacizumab; Drug: Brenetafusp and kinase inhibitors

Brenetafusp and Multimodal Therapy

EXPERIMENTAL

Participants receive brenetafusp, biologics (eg, pembrolizumab, bevacizumab) IV infusions and chemotherapy IV infusions based on histology.

Drug: Brenetafusp and monoclonal antibodies and chemotherapy

Interventions

Brenetafusp DRUG

Brenetafusp IV infusions

Brenetafusp Monotherapy

Brenetafusp and pembrolizumab DRUG

Brenetafusp and pembrolizumab IV infusions

Brenetafusp and Anti-PD(L)1 Agent

Brenetafusp and chemotherapy DRUG

Brenetafusp and chemotherapy IV infusions

Brenetafusp and Chemotherapy

Brenetafusp and monoclonal antibodies and chemotherapy DRUG

Brenetafusp and a monoclonal antibody therapy and chemotherapy

Brenetafusp and Multimodal Therapy

Brenetafusp and tebentafusp DRUG

Brenetafusp and tebentafusp IV infusions

Brenetafusp and Targeted Therapy

Brenetafusp and bevacizumab DRUG

Brenetafusp and bevacizumab IV infusions

Brenetafusp and Targeted Therapy

Brenetafusp and kinase inhibitors DRUG

Brenetafusp and oral kinase inhibitors

Brenetafusp and Targeted Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Immunocore Ltd: lead

Study Sites (76)

University of California - San Diego

La Jolla, California, 92093, United States

Location

Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

University of California Davis Comprehensive Center

Sacramento, California, 95817, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

Houston Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

University of Oklahoma Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Prisma Health

Greenville, South Carolina, 92697, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

University of Washington - Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

Location

Melanoma Institute Australia (MIA) - The Poche Centre

Wollstonecraft, New South Wales, 2065, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, 5020, Austria

Location

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

CHU de Liege

Liège, Luik, 4000, Belgium

Location

Institut Jules Bordet

Brussels, 1070, Belgium

Location

UZA

Edegem, 2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, 91350-200, Brazil

Location

D'Or Institute for Research and Education

Rio de Janeiro, Brazil

Location

National Cancer Institute

Rio de Janeiro, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, Brazil

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C4, Canada

Location

CHUM Centre de Recherche

Montreal, Quebec, H2X 0A9, Canada

Location

Institut Bergonie - Nouvelle-Aquitaine

Bordeaux, Gironde, France

Location

Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

Villejuif, Val De Marne, 94805, France

Location

Universite Claude Bernard Lyon Est

Lyon, Villeurbanne, 69100, France

Location

Hopital Saint-Louis - Centre d'Onco-Dermatologie

Paris, 75010, France

Location

Institut Curie

Paris, France

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

St Vincents University Hospital

Dublin, Ireland

Location

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

Rome, Roma, 00168, Italy

Location

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

Seriate, Roma, 00168, Italy

Location

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale

Naples, 80131, Italy

Location

Netherlands Cancer Institute

Amsterdam, CX, 1066, Netherlands

Location

UMC Groningen Comprehensive Cancer Center

Groningen, GZ, 9713, Netherlands

Location

Leiden UMC

Leiden, ZA, 2333, Netherlands

Location

New Zealand Clinical Research-Auckland

Auckland, 92697, New Zealand

Location

Centrum Medyczne Pratia Poznan - Skorzewo

Skórzewo, 60-185, Poland

Location

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

Warsaw, 02-781, Poland

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

University of Ulsan College of Medicine

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

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

Pamplona, Navarre, 31008, Spain

Location

NEXT Barcelona

Barcelona, 08023, Spain

Location

Hospital Universitario Vall dHebron

Barcelona, 08035, Spain

Location

Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

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

Madrid, 28022, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

University Hospital, Basel Switzerland

Basel, 4031, Switzerland

Location

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne, Switzerland

Location

University Hospital of Zurich

Zurich, 8058, Switzerland

Location

Sarah Cannon Research Institute UK

London, City of London, W1G6AD, United Kingdom

Location

University of Oxford

Oxford, Oxfordshire, OX3 7LI, United Kingdom

Location

The Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

University of Liverpool

Liverpool, L69 3BX, United Kingdom

Location

University College Hospital London

London, W1T7HA, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Royal Marsden Hospital

Surrey Quays, SM25PT, United Kingdom

Location

MeSH Terms

Interventions

pembrolizumab; Drug Therapy; Antibodies, Monoclonal; tebentafusp; Bevacizumab

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 10, 2020
• Study Start: February 25, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CH (3); BR (4); CA (2); AU (4); FR (5); IE (1); NZ (1); PL (2); US (22); IT (3); ES (6); KR (4); NL (3); BE (6); DE (1); GB (8)