Testing IMC-R117C for advanced cancers in specific patients
Official title: 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
Run by Immunocore Ltd · NCT06840119 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Immunocore Ltd Industry-sponsored |
| Locations | 13 sites (Darlinghurst, Sydney and 12 other locations) |
| Status | Recruiting |
| Started | January 10, 2024 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2027 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT06840119 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with untreated central nervous system metastasis or significant ongoing health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies using bispecific proteins have shown promise, suggesting potential for success in this novel approach.
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 * 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 it's running
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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
Show 7 more locations
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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 -
St Vincent's Hospital
Darlinghurst, Sydney, Australia Active not recruiting
Study contacts
- Study coordinator: Immunocore Medical Information
- 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.