Study of IMC-P115C in Advanced PRAME-Positive Cancers

NCT ID: NCT07156136

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-07

Study Completion Date

2029-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

The study will include sequential assignment for non-randomized and randomized arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: IMC-P115C Monotherapy

Participants receive IMC-P115C intravenous (IV) infusion

Group Type EXPERIMENTAL

IMC-P115C

Intervention Type DRUG

IV infusion

Interventions

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IMC-P115C

IV infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunocore Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Research South Australia (CRSA)

Adelaide, , Australia

Site Status RECRUITING

Linear Clinical Research ltd.

Nedlands, , Australia

Site Status RECRUITING

Melanoma Institute Australia

Wollstonecraft, , Australia

Site Status RECRUITING

UNICANCER - Centre Leon-Berard (CLB)

Lyon, , France

Site Status RECRUITING

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

Toulouse, , France

Site Status RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, , Italy

Site Status RECRUITING

Istituto Europeo di Oncologia

Milan, , Italy

Site Status RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"

Napoli, , Italy

Site Status RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, , Spain

Site Status RECRUITING

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

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status RECRUITING

START Madrid - Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status RECRUITING

Countries

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Australia France Italy Spain

Central Contacts

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Immunocore Medical Information Global

Role: CONTACT

844-466-8661

Immunocore Medical Information EU

Role: CONTACT

+00 800-744-51111

Other Identifiers

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2023-509767-25

Identifier Type: OTHER

Identifier Source: secondary_id

IMC-P115C-1005

Identifier Type: -

Identifier Source: org_study_id

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