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

PHASE1PHASE2ACTIVE_NOT_RECRUITING

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 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.

Eligibility criteria

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

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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1PHASE2

trial

Study 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

  • Condition: Select Advanced Solid Tumors

  • DRUG: Brenetafusp and other drugs

  • Randwick, New South Wales, Australia and more

  • Sponsor: Immunocore Ltd

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Scientia Clinical Research

Select from list below to view details:

  • Scientia Clinical Research

    Randwick, New South Wales, Australia

  • Melanoma Institute Australia (MIA) - The Poche Centre

    Wollstonecraft, New South Wales, Australia

  • The Alfred Hospital

    Melbourne, Victoria, Australia

  • Linear Clinical Research

    Nedlands, Western Australia, Australia

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Who is running the clinical trial?

IL

Immunocore Ltd

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
    EXPERIMENTAL: Brenetafusp and Anti-PD(L)1 Agent
    • Participants receive brenetafusp and pembrolizumab.
    Drug: Brenetafusp and pembrolizumab
      EXPERIMENTAL: Brenetafusp and Chemotherapy
      • Participants receive brenetafusp and chemotherapy. Choice of chemotherapy is dependent on cohort.
      Drug: Brenetafusp and chemotherapy
        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, Drug: Brenetafusp and bevacizumab, Drug: Brenetafusp and 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

            What is the study measuring?

            Primary Outcome

            MeasureDescriptionTime 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

            MeasureDescriptionTime 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
            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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