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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT) — Up to ~24 months
Dose Escalation: Percentage of participants with ≥1 adverse event (AE) — Up to ~24 months
Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE) — Up to ~24 months
Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings — Up to ~24 months
Dose Escalation: Percentage of participants with significant changes in vital signs — Up to ~24 months
Dose Escalation: Percentage of participants with significant changes in laboratory results — Up to ~24 months
Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation — Up to ~24 months
Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1 — Up to ~24 months
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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