Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers
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.
| Condition(s) | Cancer, HLA-A*02:01-positive |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Immunocore Ltd |
| Locations | Darlinghurst, Sydney, Australia; Melbourne, Australia; Anderlecht, Belgium; Ghent, Belgium; Leuven, Belgium; Heidelberg, Germany (+7 more sites) |
| Start date | 2024-01-10 |
| NCT ID | NCT06840119 |
| Official listing | https://clinicaltrials.gov/study/NCT06840119 |