Testing IMC-R117C for advanced cancers in specific patients
A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a Single Agent and in Combination in HLA-A*02:01-Positive Participants With Selected Advanced PIWIL1-Positive Cancers
PHASE1; PHASE2 · Immunocore Ltd · NCT06840119
This study is testing a new treatment called IMC-R117C to see if it can help people with advanced cancers like colorectal, esophageal, gastric, or ovarian cancer who have already tried other therapies.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Immunocore Ltd (industry) |
| Locations | 13 sites (Darlinghurst, Sydney and 12 other locations) |
| Trial ID | NCT06840119 on ClinicalTrials.gov |
What this trial studies
This phase 1/2 study aims to evaluate the safety and effectiveness of IMC-R117C, a bispecific protein, in patients with advanced cancers who are HLA-A*02:01-positive. Participants will receive IMC-R117C either alone or in combination with other cancer therapies, including chemotherapy and kinase inhibitors. The study focuses on individuals with advanced colorectal, esophageal, gastric, or ovarian carcinoma who have previously undergone standard treatments. The trial will assess the response of measurable disease using established criteria.
Who should consider this trial
Good fit: Ideal candidates are HLA-A*02:01-positive individuals with advanced colorectal, esophageal, gastric, or ovarian carcinoma who have a good performance status.
Not a fit: Patients with untreated central nervous system metastasis or significant ongoing health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that are currently difficult to treat.
How similar studies have performed: Other studies using bispecific proteins have shown promise, suggesting potential for success in this novel approach.
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 * Histologically confirmed advanced colorectal, esophageal, gastric, or ovarian carcinoma * Archived or fresh tumor tissue sample that must be confirmed as adequate * Evaluable/Measurable disease per RECIST 1.1 * Previously received applicable standard treatments * 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 * Recent bowel obstruction * 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
Darlinghurst, Sydney and 12 other locations
- St Vincent's Hospital — Darlinghurst, Sydney, Australia (ACTIVE_NOT_RECRUITING)
- Peter MacCallum Cancer Centre — Melbourne, Australia (RECRUITING)
- Institut Jules Bordet — Anderlecht, Belgium (RECRUITING)
- Universitair Ziekenhuis Gent — Ghent, Belgium (RECRUITING)
- UZ Leuven — Leuven, Belgium (RECRUITING)
- Universitaetsklinikum Heidelberg — Heidelberg, Germany (RECRUITING)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (RECRUITING)
- nstituto Clinico Humanitas — Rozzano, Italy (RECRUITING)
- Antoni van Leeuwenhoek — Amsterdam, Netherlands (RECRUITING)
- Hospital HM Nou Delfos — Barcelona, Spain (RECRUITING)
- VHIO, Vall d'Hebron University Hospital — Barcelona, Spain (RECRUITING)
- Centro Integral Oncologico Clara Campal — Madrid, Spain (RECRUITING)
- Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: Immunocore Medical Information
- 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: Cancer, HLA-A*02:01-positive