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

PHASE1PHASE2RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2020-02-25

    Primary completion: 2026-02-01

    Study completion finish: 2026-08-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT04262466

    Intervention or treatment

    DRUG: Brenetafusp

    DRUG: Brenetafusp and pembrolizumab

    DRUG: Brenetafusp and chemotherapy

    DRUG: Brenetafusp and monoclonal antibodies and chemotherapy

    DRUG: Brenetafusp and tebentafusp

    DRUG: Brenetafusp and bevacizumab

    DRUG: Brenetafusp and kinase inhibitors

    Conditions

    • • Select Advanced Solid Tumors
    Image related to Select Advanced Solid Tumors

    • Condition: Select Advanced Solid Tumors

    • DRUG: Brenetafusp and other drugs

    • Randwick, New South Wales, Australia and more

    • Sponsor: Immunocore Ltd

    You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

    Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

    Find a site

    Closest Location:

    Scientia Clinical Research

    Research sites nearby

    Select from list below to view details:

    • Scientia Clinical Research

      Randwick, New South Wales, Australia

    • The Alfred Hospital

      Melbourne, Victoria, Australia

    • Melanoma Institute Australia (MIA) - The Poche Centre

      Wollstonecraft, New South Wales, Australia

    • Linear Clinical Research

      Nedlands, Western Australia, Australia

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    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?

    Participant Group/ArmIntervention/Treatment
    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
    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

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Phase 1: Incidence of dose-limiting toxicity (DLT)sNot SpecifiedUp to ~28 days after each dose
    Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE)Not SpecifiedUp to 30 days after the last dose of study therapy
    Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuationsNot SpecifiedUp to ~12 months
    Phase 1: Number of participants with abnormal laboratory test results (hematology)Not SpecifiedUp to 30 days after the last dose of study therapy
    Phase 1: Number of participants with abnormal laboratory test results (chemistry)Not SpecifiedUp to 30 days after the last dose of study therapy
    Phase 1: Number of participants with abnormal laboratory test results (coagulation)Not SpecifiedUp to 30 days after the last dose of study therapy
    Phase 1: Number of participants with abnormal urinalysisNot SpecifiedUp to 30 days after the last dose of study therapy
    Phase 1: Number of participants with abnormal vital signsNot SpecifiedUp to 30 days after the last dose of study therapy
    Phase 1: Mean change from baseline in QTcF intervalNot SpecifiedUp to 30 days after the last dose of study therapy
    Phase 2: Best overall response (BOR)Not SpecifiedUp to ~2 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Phase I: Best Overall Response (BOR)Not SpecifiedUp to ~2 years
    Progression-free survival (PFS)Not SpecifiedUp to ~2 years
    Duration of response (DOR)Not SpecifiedUp to ~2 years
    Overall survivalNot SpecifiedUp to ~2 years
    Area under the plasma concentration-time curve (AUC) of brenetafuspNot SpecifiedAt designated time points up to ~3 weeks
    Maximum plasma drug concentration (Cmax) of brenetafuspNot SpecifiedAt designated time points up to ~3 weeks
    Time to reach maximum plasma concentration (Tmax) of brenetafuspNot SpecifiedAt designated time points up to ~3 weeks
    Plasma elimination half-life (t½) of brenetafuspNot SpecifiedAt designated time points up to ~3 weeks
    Incidence of anti-brenetafusp antibody formationNot SpecifiedUp to ~ 2 years
    Changes in lymphocyte counts over timeNot SpecifiedUp to ~3 weeks
    Changes in serum cytokines over timeNot SpecifiedUp to ~3 weeks
    Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteriaNot SpecifiedUp to ~2 years

    Frequently Asked Questions

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    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

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

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