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Select Advanced Solid TumorsPhase 1/2NCT04262466

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

A Phase 1/2 study testing Brenetafusp, Brenetafusp and pembrolizumab and Brenetafusp and chemotherapy in people with Select Advanced Solid Tumors, run by Immunocore Ltd at 76 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Select Advanced Solid Tumors
What is being tested?
Brenetafusp, Brenetafusp and pembrolizumab and Brenetafusp and chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
410 participants
Where
76 sitesin 17 countries
Study dates
25 Feb 2020to Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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
  • Any other contraindication for applicable combination partner based on local prescribing information

Trial locations and contacts

76 sites in 17 countries.

76 sites in 17 countries

United States22 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Prisma Health

    Greenville, South Carolina, 92697

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of California - San Diego

    La Jolla, California, 92093

  • Angeles Clinic and Research Institute

    Los Angeles, California, 90025

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering

    New York, New York, 10065

  • University of Oklahoma Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • University of California Davis Comprehensive Center

    Sacramento, California, 95817

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of Washington - Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Houston Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20057

Other trials in United States

United Kingdom8 sites

  • The Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 0YN

  • University of Liverpool

    Liverpool, L69 3BX

  • Sarah Cannon Research Institute UK

    London, City of London, W1G6AD

  • University College Hospital London

    London, W1T7HA

  • Guy's and St Thomas' NHS Foundation Trust

    London

  • The Christie NHS Foundation Trust

    Manchester

  • University of Oxford

    Oxford, Oxfordshire, OX3 7LI

  • Royal Marsden Hospital

    Surrey Quays, SM25PT

Other trials in United Kingdom

Belgium6 sites

  • Institut Jules Bordet

    Brussels, 1070

  • UZA

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitair Ziekenhuis Brussel

    Jette, Brussels Capital, 1090

  • UZ Leuven

    Leuven, 3000

  • CHU de Liege

    Liège, Luik, 4000

Other trials in Belgium

Spain6 sites

  • NEXT Barcelona

    Barcelona, 08023

  • Hospital Universitario Vall dHebron

    Barcelona, 08035

  • Hospital Duran i Reynals

    Barcelona, 08908

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

    Madrid, 28022

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

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

    Pamplona, Navarre, 31008

Other trials in Spain

France5 sites

  • Institut Bergonie - Nouvelle-Aquitaine

    Bordeaux, Gironde

  • Universite Claude Bernard Lyon Est

    Lyon, Villeurbanne, 69100

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

    Paris, 75010

  • Institut Curie

    Paris

  • Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

    Villejuif, Val De Marne, 94805

Other trials in France

Australia4 sites

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Linear Clinical Research

    Nedlands, Western Australia, 6009

  • Scientia Clinical Research

    Randwick, New South Wales, 2031

  • Melanoma Institute Australia (MIA) - The Poche Centre

    Wollstonecraft, New South Wales, 2065

Other trials in Australia

Brazil4 sites

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, 91350-200

  • D'Or Institute for Research and Education

    Rio de Janeiro

  • National Cancer Institute

    Rio de Janeiro

  • Hospital Israelita Albert Einstein

    São Paulo

Other trials in Brazil

South Korea4 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Yonsei University College of Medicine

    Seoul, 03722

  • University of Ulsan College of Medicine

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Italy3 sites

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale

    Naples, 80131

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

    Rome, Roma, 00168

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

    Seriate, Roma, 00168

Other trials in Italy

Netherlands3 sites

  • Netherlands Cancer Institute

    Amsterdam, CX, 1066

  • UMC Groningen Comprehensive Cancer Center

    Groningen, GZ, 9713

  • Leiden UMC

    Leiden, ZA, 2333

Other trials in Netherlands

Switzerland3 sites

  • University Hospital, Basel Switzerland

    Basel, 4031

  • Centre Hospitalier Universitaire Vaudois Lausanne

    Lausanne

  • University Hospital of Zurich

    Zurich, 8058

Other trials in Switzerland

Canada2 sites

  • CHUM Centre de Recherche

    Montreal, Quebec, H2X 0A9

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Poland2 sites

  • Centrum Medyczne Pratia Poznan - Skorzewo

    Skórzewo, 60-185

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

    Warsaw, 02-781

Other trials in Poland

Austria1 site

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

Other trials in Austria

Germany1 site

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

Other trials in Germany

Ireland1 site

  • St Vincents University Hospital

    Dublin

Other trials in Ireland

New Zealand1 site

  • New Zealand Clinical Research-Auckland

    Auckland, 92697

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.
Being tested
Brenetafusp, Brenetafusp and pembrolizumab, Brenetafusp and chemotherapy, Brenetafusp and monoclonal antibodies and chemotherapy, Brenetafusp and tebentafusp

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrenetafuspDrug

    Brenetafusp IV infusions

  • Brenetafusp and pembrolizumabDrug

    Brenetafusp and pembrolizumab IV infusions

  • Brenetafusp and chemotherapyDrug

    Brenetafusp and chemotherapy IV infusions

  • Brenetafusp and monoclonal antibodies and chemotherapyDrug

    Brenetafusp and a monoclonal antibody therapy and chemotherapy

  • Brenetafusp and tebentafuspDrug

    Brenetafusp and tebentafusp IV infusions

  • Brenetafusp and bevacizumabDrug

    Brenetafusp and bevacizumab IV infusions

  • Brenetafusp and kinase inhibitorsDrug

    Brenetafusp and oral kinase inhibitors

Study groups in NCT04262466
Study groupRoleWhat they receive
Brenetafusp MonotherapyExperimentalParticipants receive brenetafusp.
Receives: Drug: Brenetafusp
Brenetafusp and Anti-PD(L)1 AgentExperimentalParticipants receive brenetafusp and pembrolizumab.
Receives: Drug: Brenetafusp and pembrolizumab
Brenetafusp and ChemotherapyExperimentalParticipants receive brenetafusp and chemotherapy. Choice of chemotherapy is dependent on cohort.
Receives: Drug: Brenetafusp and chemotherapy
Brenetafusp and Targeted TherapyExperimentalParticipants receive brenetafusp and a selected targeted therapy. Receipt of kinase inhibitor is dependent on histology.
Receives: Drug: Brenetafusp and tebentafusp; Drug: Brenetafusp and bevacizumab; Drug: Brenetafusp and kinase inhibitors
Brenetafusp and Multimodal TherapyExperimentalParticipants receive brenetafusp, biologics (eg, pembrolizumab, bevacizumab) IV infusions and chemotherapy IV infusions based on histology.
Receives: Drug: Brenetafusp and monoclonal antibodies and chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Incidence of dose-limiting toxicity (DLT)s

    Measured: Up to ~28 days after each dose

  2. Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE)

    Measured: Up to 30 days after the last dose of study therapy

  3. Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations

    Measured: Up to ~12 months

  4. Phase 1: Number of participants with abnormal laboratory test results (hematology)

    Measured: Up to 30 days after the last dose of study therapy

  5. Phase 1: Number of participants with abnormal laboratory test results (chemistry)

    Measured: Up to 30 days after the last dose of study therapy

  6. Phase 1: Number of participants with abnormal laboratory test results (coagulation)

    Measured: Up to 30 days after the last dose of study therapy

  7. Phase 1: Number of participants with abnormal urinalysis

    Measured: Up to 30 days after the last dose of study therapy

  8. Phase 1: Number of participants with abnormal vital signs

    Measured: Up to 30 days after the last dose of study therapy

  9. Phase 1: Mean change from baseline in QTcF interval

    Measured: Up to 30 days after the last dose of study therapy

  10. Phase 2: Best overall response (BOR)

    Measured: Up to ~2 years

Secondary outcomes (12)

  1. Phase I: Best Overall Response (BOR)

    Measured: Up to ~2 years

  2. Progression-free survival (PFS)

    Measured: Up to ~2 years

  3. Duration of response (DOR)

    Measured: Up to ~2 years

  4. Overall survival

    Measured: Up to ~2 years

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

    Measured: At designated time points up to ~3 weeks

  6. Maximum plasma drug concentration (Cmax) of brenetafusp

    Measured: At designated time points up to ~3 weeks

  7. Time to reach maximum plasma concentration (Tmax) of brenetafusp

    Measured: At designated time points up to ~3 weeks

  8. Plasma elimination half-life (t½) of brenetafusp

    Measured: At designated time points up to ~3 weeks

  9. Incidence of anti-brenetafusp antibody formation

    Measured: Up to ~ 2 years

  10. Changes in lymphocyte counts over time

    Measured: Up to ~3 weeks

  11. Changes in serum cytokines over time

    Measured: Up to ~3 weeks

  12. Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteria

    Measured: Up to ~2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2020
  2. Study start25 Feb 2020
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04262466
Sponsor's protocol ID
IMC-F106C-101
Status last verified
Mar 2026
First submitted
30 Jan 2020
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Brenetafusp, Brenetafusp and pembrolizumab and Brenetafusp and chemotherapy in people with Select Advanced Solid Tumors, run by Immunocore Ltd at 76 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, United Kingdom, Belgium, Spain, France and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Incidence of dose-limiting toxicity (DLT)s (time frame: Up to ~28 days after each dose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04262466.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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