IMC-P115C treatment for advanced PRAME-positive cancers
Official 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
Run by Immunocore Ltd · NCT07156136 · Data updated 2026-11-12
This phase 1 study tests a new immune-engaging drug called IMC-P115C, alone or with standard treatments, in people with advanced PRAME-positive, HLA-A*02:01-positive cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Immunocore Ltd Industry-sponsored |
| Locations | 13 sites (Adelaide and 12 other locations) |
| Status | Recruiting |
| Started | November 7, 2024 |
| Main results expected | September 30, 2027 |
| Study ends | August 30, 2029 |
| Registry record updated | February 25, 2026 |
| Trial ID | NCT07156136 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with metastatic or unresectable PRAME-positive solid tumors who are HLA-A*02:01-positive, have ECOG 0–1, and have progressed on or are intolerant to standard therapies.
✕Probably not a fit
Patients without PRAME expression or the HLA-A*02:01 type, those with untreated symptomatic brain metastases, ongoing need for immunosuppression, or significant organ dysfunction are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first-in-human, phase 1 trial of IMC-P115C, a half-life–extended ImmTAC designed to redirect T cells to cancer cells expressing PRAME. The drug will be given as a single agent and in combination with standard-of-care therapies to adults with metastatic or unresectable PRAME-positive solid tumors who are HLA-A*02:01-positive. The study will enroll patients with ECOG performance status 0–1 and use dose-escalation to define safety, tolerability, a recommended dose, and to look for early signs of anti-tumor activity. Tumor PRAME testing and HLA typing are required, and participants with uncontrolled CNS metastases or significant comorbidities are excluded.
Why it matters
Potential benefit: If successful, IMC-P115C could help the immune system target PRAME-expressing tumors and potentially shrink or control disease in patients with limited treatment options.
How similar studies have gone: This is the first human study of IMC-P115C, but the ImmTAC platform has produced clinical successes such as tebentafusp, showing that similar TCR-based redirected T cell approaches can work.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Cancer Research South Australia (CRSA)
Adelaide, Australia Recruiting -
Linear Clinical Research ltd.
Nedlands, Australia Recruiting -
Melanoma Institute Australia
Wollstonecraft, Australia Recruiting -
UNICANCER - Centre Leon-Berard (CLB)
Lyon, France Recruiting -
Centre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
Toulouse, France Recruiting -
Institut Gustave Roussy
Villejuif, France Recruiting
Show 7 more locations
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Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, Italy Recruiting -
Istituto Europeo di Oncologia
Milan, Italy Recruiting -
Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
Naples, Italy Recruiting -
Hospital Universitari Vall d Hebron
Barcelona, Spain Recruiting -
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
Barcelona, Spain Recruiting -
Hospital Universitario Ramon y Cajal
Madrid, Spain Recruiting -
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain Recruiting
Study contacts
- Study coordinator: Immunocore Medical Information Global
- Email: medical.information@immunocore.com
- Phone: 844-466-8661
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.