IMC-P115C treatment for advanced PRAME-positive cancers
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
PHASE1 · Immunocore Ltd · NCT07156136
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 | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Immunocore Ltd (industry) |
| Locations | 13 sites (Adelaide and 12 other locations) |
| Trial ID | NCT07156136 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Adelaide and 12 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PRAME Positive, Cancer, HLA-A*02:01-positive, PRAME