Overview
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.
Eligibility
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