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NCT Number: NCT07156136

Study of IMC-P115C in Advanced PRAME-Positive Cancers

Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Research South Australia (CRSA), Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • HLA-A*02:01-positive
  • Meeting PRAME-positive tumor testing requirements
  • Metastatic or unresectable solid tumors
  • Have received (or be receiving), relapsed from, be refractory to or intolerant of all therapies
  • Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control

Exclusion criteria

  • Symptomatic or untreated central nervous system metastasis
  • Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment
  • Ongoing ascites or effusion requiring recent drainages
  • Significant ongoing toxicity from prior anticancer treatment
  • Out-of-range laboratory values
  • Clinically significant lung, heart, or autoimmune disease
  • Ongoing requirement for immunosuppressive treatment
  • Significant secondary malignancy
  • Hypersensitivity to study drug or excipients
  • Pregnant or lactating

Treatment and study plan

IMC-P115C

Drug

IV infusion

Primary outcomes

  1. Percentage of participants with dose-limiting toxicities (DLT)

    Time frame: Up to ~16 months

  2. Percentage of participants with adverse events (AE)

    Time frame: Up to ~16 months

  3. Percentage of participants with serious adverse events (SAE)

    Time frame: Up to ~16 months

  4. Percentage of participants with a dose interruption, reduction, or discontinuation

    Time frame: Up to ~16 months

    Percentage of participants with dosing changes or discontinuations.

Secondary outcomes

  1. Best Overall Response (BOR) as determined by RECIST v1.1 per the Investigator.

    Time frame: Up to ~19 months

  2. Duration of Response (DOR) as determined by RECIST v1.1 per the Investigator.

    Time frame: Up to ~19 months

  3. Progression Free Survival (PFS) as determined by RECIST v1.1 per the Investigator.

    Time frame: Up to ~19 months

  4. Overall Survival (OS)

    Time frame: Up to ~19 months

    OS is the time from first dose of study therapy until death due to any cause.

  5. Change from baseline in lymphocyte counts

    Time frame: Up to ~19 months

    Change from baseline in lymphocyte counts

  6. Changes in serum cytokine concentrations

    Time frame: Up to ~19 months

    Change from baseline in serum cytokine concentrations

  7. IMC-P115C Plasma Concentration

    Time frame: Up to ~19 months

    IMC-P115C plasma concentration

  8. Percentage of participants with anti-IMC-P115C antibody formation

    Time frame: Up to ~19 months

Study contacts

Contact information is provided by the study sponsor or research team.

Immunocore Medical Information EU

CONTACT

[email protected]

+00 800-744-51111

Immunocore Medical Information Global

CONTACT

[email protected]

844-466-8661

Sponsors and collaborators

Lead sponsor

Immunocore Ltd

Industry

Registry information

Official study title

A Phase 1 First-in-Human Study of the Safety and Efficacy of IMC-P115C as a Single Agent and in Combination With Standard of Care Agents in HLA-A*02:01 Positive Participants With Advanced PRAME Positive Cancers

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Sep 4, 2025
Registry last updated
Feb 25, 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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