Study of IMC-P115C in Advanced PRAME-Positive Cancers

NCT07156136 | Recruiting Phase 1 DMC

• 2 other identifiers: IMC-P115C-10052023-509767-25
• Study Type: interventional
• Target: 140
• Locations: 4 countries
• Sites: 13

Brief Summary

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.

Conditions

HLA-A*02:01-positive; PRAME Positive; Cancer

Keywords

PRAME

Outcome Measures

Primary Outcomes (4)

• Percentage of participants with dose-limiting toxicities (DLT)

  Up to ~16 months

• Percentage of participants with adverse events (AE)

  Up to ~16 months

• Percentage of participants with serious adverse events (SAE)

  Up to ~16 months

• Percentage of participants with a dose interruption, reduction, or discontinuation

  Percentage of participants with dosing changes or discontinuations.

  Up to ~16 months

Secondary Outcomes (8)

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

  Up to ~19 months

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

  Up to ~19 months

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

  Up to ~19 months

• Overall Survival (OS)

  Up to ~19 months

• Change from baseline in lymphocyte counts

  Up to ~19 months

Study Arms (1)

Arm A: IMC-P115C Monotherapy

EXPERIMENTAL

Participants receive IMC-P115C intravenous (IV) infusion

Drug: IMC-P115C

Interventions

IMC-P115C DRUG

IV infusion

Arm A: IMC-P115C Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Immunocore Ltd: lead

Study Sites (13)

Cancer Research South Australia (CRSA)

Adelaide, 5000, Australia

RECRUITING

Linear Clinical Research ltd.

Nedlands, 06009, Australia

RECRUITING

Melanoma Institute Australia

Wollstonecraft, 2065, Australia

RECRUITING

UNICANCER - Centre Leon-Berard (CLB)

Lyon, 69008, France

RECRUITING

Centre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)

Toulouse, 31059, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"

Naples, 80131, Italy

RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, 08035, Spain

RECRUITING

Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals

Barcelona, 08908, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

START Madrid - Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Immunocore Medical Information Global

CONTACT

844-466-8661; medical.information@immunocore.com

Immunocore Medical Information EU

CONTACT

+00 800-744-51111; medinfo.eu@immunocore.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will include sequential assignment for non-randomized and randomized arms.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: November 7, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): August 30, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

AU (3); ES (4); FR (3); IT (3)