Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers
Recruiting now · Phase 1/Phase 2
Conditions studied: Cancer, HLA-A*02:01-positive
In brief
This phase 1/2 first-in-human study is designed to test the safety and efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a single agent and in combination with other therapies in HLA-A\*02:01-positive participants with selected advanced PIWIL1-Positive cancers.
Key facts
- Study ID
- NCT06840119
- Run by
- Immunocore Ltd
- People needed
- 600
- Starts
- 2024-01-10
- Expected to finish
- 2027-11-30
- Last updated by the study team
- 2026-01-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain (enrolling)
- Peter MacCallum Cancer Centre — Melbourne, Australia (enrolling)
- Institut Jules Bordet — Anderlecht, Belgium (enrolling)
- Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
- UZ Leuven — Leuven, Belgium (enrolling)
- Universitaetsklinikum Heidelberg — Heidelberg, Germany (enrolling)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (enrolling)
- nstituto Clinico Humanitas — Rozzano, Italy (enrolling)
- Antoni van Leeuwenhoek — Amsterdam, Netherlands (enrolling)
- Hospital HM Nou Delfos — Barcelona, Spain (enrolling)
- VHIO, Vall d'Hebron University Hospital — Barcelona, Spain (enrolling)
- Centro Integral Oncologico Clara Campal — Madrid, Spain (enrolling)
- St Vincent's Hospital — Darlinghurst, Sydney, Australia
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.