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NCT Number: NCT04262466

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Select Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Scientia Clinical Research, Randwick, New South Wales, Australia

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About this study

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.

  • 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.
  • Phase 2: To assess the efficacy of brenetafusp in selected advanced solid tumors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Any other contraindication for applicable combination partner based on local prescribing information

Treatment and study plan

Brenetafusp

Drug

Brenetafusp IV infusions

Brenetafusp and pembrolizumab

Drug

Brenetafusp and pembrolizumab IV infusions

Brenetafusp and chemotherapy

Drug

Brenetafusp and chemotherapy IV infusions

Brenetafusp and monoclonal antibodies and chemotherapy

Drug

Brenetafusp and a monoclonal antibody therapy and chemotherapy

Brenetafusp and tebentafusp

Drug

Brenetafusp and tebentafusp IV infusions

Brenetafusp and bevacizumab

Drug

Brenetafusp and bevacizumab IV infusions

Brenetafusp and kinase inhibitors

Drug

Brenetafusp and oral kinase inhibitors

Primary outcomes

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

    Time frame: Up to ~28 days after each dose

  2. 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

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

    Time frame: Up to ~12 months

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

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

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

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

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

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

  7. Phase 1: Number of participants with abnormal urinalysis

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

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

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

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

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

  10. Phase 2: Best overall response (BOR)

    Time frame: Up to ~2 years

Secondary outcomes

  1. Phase I: Best Overall Response (BOR)

    Time frame: Up to ~2 years

  2. Progression-free survival (PFS)

    Time frame: Up to ~2 years

  3. Duration of response (DOR)

    Time frame: Up to ~2 years

  4. Overall survival

    Time frame: Up to ~2 years

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

    Time frame: At designated time points up to ~3 weeks

  6. Maximum plasma drug concentration (Cmax) of brenetafusp

    Time frame: At designated time points up to ~3 weeks

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

    Time frame: At designated time points up to ~3 weeks

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

    Time frame: At designated time points up to ~3 weeks

  9. Incidence of anti-brenetafusp antibody formation

    Time frame: Up to ~ 2 years

  10. Changes in lymphocyte counts over time

    Time frame: Up to ~3 weeks

  11. Changes in serum cytokines over time

    Time frame: Up to ~3 weeks

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

    Time frame: Up to ~2 years

Sponsors and collaborators

Lead sponsor

Immunocore Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Feb 10, 2020
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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