Active — Not RecruitingPhase 1/2

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

United States410 participantsStarted 2020-02-25

Plain-language 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. 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Up to ~28 days after each dose

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

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

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

Timeframe: Up to ~12 months

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

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

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

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

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

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

Phase 1: Number of participants with abnormal urinalysis

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

Trial details

NCT IDNCT04262466

SponsorImmunocore Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Select Advanced Solid Tumors trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Up to ~28 days after each dose

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

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

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

Timeframe: Up to ~12 months

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

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

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

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

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

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

Phase 1: Number of participants with abnormal urinalysis

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