Clinical trial · Interventional
Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers
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
NCT06840119CI-TRIAL-00101764recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| HLA-A*02:01-positive | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antiangiogenic Agent | Drug | — | UNRESOLVED |
| Chemotherapy drug | Drug | — | UNRESOLVED |
| IMC-R117C | Drug | — | UNRESOLVED |
| Kinase inhibitor | Drug | — | UNRESOLVED |
| Monoclonal antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm A: IMC-R117C Monotherapy Dose-Escalation
- description
- Participants receive IMC-R117C intravenous (IV) infusion.
- interventionNames
- Drug: IMC-R117C
- type
- EXPERIMENTAL
- label
- Arm B: IMC-R117C Combination Dose-Escalation
- description
- Participants receive IMC-R117C IV infusion in combination with standard of care chemotherapy and antiangiogenic agent
- interventionNames
- Drug: IMC-R117C
- Drug: Chemotherapy drug
- Drug: Antiangiogenic Agent
- type
- EXPERIMENTAL
- label
- Arm C: IMC-R117C Combination Dose-Escalation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.