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

March 4, 2026 updated by: Immunocore Ltd

Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Scientia Clinical Research
      • Wollstonecraft, New South Wales, Australia, 2065
        • Melanoma Institute Australia (MIA) - The Poche Centre
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research
  • Austria
      • Salzburg, Austria, 5020
        • Lkh - Universitatsklinikum Der Pmu Salzburg
  • Belgium
      • Brussels, Belgium, 1070
        • Institut Jules Bordet
      • Edegem, Belgium, 2650
        • UZA
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
    • Brussels Capital
      • Jette, Brussels Capital, Belgium, 1090
        • Universitair Ziekenhuis Brussel
    • Luik
      • Liège, Luik, Belgium, 4000
        • CHU de Liege
  • Brazil
      • Porto Alegre, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
      • Rio de Janeiro, Brazil
        • D'OR Institute for Research and Education
      • Rio de Janeiro, Brazil
        • National Cancer Institute
      • São Paulo, Brazil
        • Hospital israelita Albert Einstein
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • CHUM Centre de Recherche
  • France
      • Paris, France
        • Institut Curie
      • Paris, France, 75010
        • Hopital Saint-Louis - Centre d'Onco-Dermatologie
    • Gironde
      • Bordeaux, Gironde, France
        • Institut Bergonie - Nouvelle-Aquitaine
    • Val De Marne
      • Villejuif, Val De Marne, France, 94805
        • Gustave Roussy (Institut de Cancerologie Gustave-Roussy)
    • Villeurbanne
      • Lyon, Villeurbanne, France, 69100
        • Universite Claude Bernard Lyon Est
  • Germany
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
  • Ireland
      • Dublin, Ireland
        • St Vincents University Hospital
  • Italy
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
    • Roma
      • Rome, Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche
      • Seriate, Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Patologia Ostetrica e Ginecologica
  • Netherlands
    • CX
      • Amsterdam, CX, Netherlands, 1066
        • Netherlands Cancer Institute
    • GZ
      • Groningen, GZ, Netherlands, 9713
        • UMC Groningen Comprehensive Cancer Center
    • ZA
      • Leiden, ZA, Netherlands, 2333
        • Leiden UMC
  • New Zealand
      • Auckland, New Zealand, 92697
        • New Zealand Clinical Research-Auckland
  • Poland
      • Skórzewo, Poland, 60-185
        • Centrum Medyczne Pratia Poznan - Skorzewo
      • Warsaw, Poland, 02-781
        • Narodowy Instytut Onkologii Im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Yonsei University College of Medicine
      • Seoul, South Korea, 05505
        • University of Ulsan College of Medicine
  • Spain
      • Barcelona, Spain, 08908
        • Hospital Duran i Reynals
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall Dhebron
      • Barcelona, Spain, 08023
        • NEXT Barcelona
      • Madrid, Spain, 28040
        • Hospital Universitario Fundación Jiménez Díaz
      • Madrid, Spain, 28022
        • Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital, Basel Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois Lausanne
      • Zurich, Switzerland, 8058
        • University Hospital of Zurich
  • United Kingdom
      • Liverpool, United Kingdom, L69 3BX
        • University of Liverpool
      • London, United Kingdom
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, W1T7HA
        • University College Hospital London
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
      • Surrey Quays, United Kingdom, SM25PT
        • Royal Marsden Hospital
    • City of London
      • London, City of London, United Kingdom, W1G6AD
        • Sarah Cannon Research Institute UK
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LI
        • University of Oxford
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • The Beatson West of Scotland Cancer Centre
  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California - San Diego
      • Los Angeles, California, United States, 90025
        • Angeles Clinic and Research Institute
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20057
        • Georgetown University Medical Center
    • Florida
      • Tampa, Florida, United States, 33612
        • Houston Lee Moffitt Cancer Center & Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Peggy and Charles Stephenson Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 92697
        • Prisma Health
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah - Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington - Fred Hutchinson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brenetafusp Monotherapy
Participants receive brenetafusp.
Drug: Brenetafusp
Brenetafusp IV infusions
Experimental: Brenetafusp and Anti-PD(L)1 Agent
Participants receive brenetafusp and pembrolizumab.
Drug: Brenetafusp and pembrolizumab
Brenetafusp and pembrolizumab IV infusions
Experimental: Brenetafusp and Chemotherapy
Participants receive brenetafusp and chemotherapy. Choice of chemotherapy is dependent on cohort.
Drug: Brenetafusp and chemotherapy
Brenetafusp and chemotherapy IV infusions
Experimental: Brenetafusp and Targeted Therapy
Participants receive brenetafusp and a selected targeted therapy. Receipt of kinase inhibitor is dependent on histology.
Drug: Brenetafusp and tebentafusp
Brenetafusp and tebentafusp IV infusions
Drug: Brenetafusp and bevacizumab
Brenetafusp and bevacizumab IV infusions
Drug: Brenetafusp and kinase inhibitors
Brenetafusp and oral kinase inhibitors
Experimental: Brenetafusp and Multimodal Therapy
Participants receive brenetafusp, biologics (eg, pembrolizumab, bevacizumab) IV infusions and chemotherapy IV infusions based on histology.
Drug: Brenetafusp and monoclonal antibodies and chemotherapy
Brenetafusp and a monoclonal antibody therapy and chemotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Phase 1: Incidence of dose-limiting toxicity (DLT)s
Time Frame: Up to ~28 days after each dose
Up to ~28 days after each dose
Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE)
Time Frame: Up to 30 days after the last dose of study therapy
Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal laboratory test results (hematology)
Time Frame: Up to 30 days after the last dose of study therapy
Up to 30 days after the last dose of study therapy
Phase 1: Mean change from baseline in QTcF interval
Time Frame: Up to 30 days after the last dose of study therapy
Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations
Time Frame: Up to ~12 months
Up to ~12 months
Phase 1: Number of participants with abnormal laboratory test results (chemistry)
Time Frame: Up to 30 days after the last dose of study therapy
Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal laboratory test results (coagulation)
Time Frame: Up to 30 days after the last dose of study therapy
Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal urinalysis
Time Frame: Up to 30 days after the last dose of study therapy
Up to 30 days after the last dose of study therapy
Phase 1: Number of participants with abnormal vital signs
Time Frame: Up to 30 days after the last dose of study therapy
Up to 30 days after the last dose of study therapy
Phase 2: Best overall response (BOR)
Time Frame: Up to ~2 years
Up to ~2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Phase I: Best Overall Response (BOR)
Time Frame: Up to ~2 years
Up to ~2 years
Progression-free survival (PFS)
Time Frame: Up to ~2 years
Up to ~2 years
Duration of response (DOR)
Time Frame: Up to ~2 years
Up to ~2 years
Overall survival
Time Frame: Up to ~2 years
Up to ~2 years
Area under the plasma concentration-time curve (AUC) of brenetafusp
Time Frame: At designated time points up to ~3 weeks
At designated time points up to ~3 weeks
Maximum plasma drug concentration (Cmax) of brenetafusp
Time Frame: At designated time points up to ~3 weeks
At designated time points up to ~3 weeks
Time to reach maximum plasma concentration (Tmax) of brenetafusp
Time Frame: At designated time points up to ~3 weeks
At designated time points up to ~3 weeks
Plasma elimination half-life (t½) of brenetafusp
Time Frame: At designated time points up to ~3 weeks
At designated time points up to ~3 weeks
Incidence of anti-brenetafusp antibody formation
Time Frame: Up to ~ 2 years
Up to ~ 2 years
Changes in lymphocyte counts over time
Time Frame: Up to ~3 weeks
Up to ~3 weeks
Changes in serum cytokines over time
Time Frame: Up to ~3 weeks
Up to ~3 weeks
Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteria
Time Frame: Up to ~2 years
Up to ~2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Immunocore Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shaad Abdullah, MD, Immunocore Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMC-F106C-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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