Clinical trial · Interventional
Study of IMC-P115C in Advanced PRAME-Positive Cancers
A Phase 1 First-in-Human Study of the Safety and Efficacy of IMC-P115C as a Single Agent and in Combination With Standard of Care Agents in HLA-A*02:01 Positive Participants With Advanced PRAME Positive Cancers
NCT07156136CI-TRIAL-00104088recruitingPhase 1ClinicalTrials.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)
Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.
Conditions
Conditions (3)
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 | — |
| PRAME Positive | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMC-P115C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A: IMC-P115C Monotherapy
- description
- Participants receive IMC-P115C intravenous (IV) infusion
- interventionNames
- Drug: IMC-P115C
Primary outcomes (4)
- measure
- Percentage of participants with dose-limiting toxicities (DLT)
- timeFrame
- Up to ~16 months
- measure
- Percentage of participants with adverse events (AE)
- timeFrame
- Up to ~16 months
- measure
- Percentage of participants with serious adverse events (SAE)
- timeFrame
- Up to ~16 months
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 * Meeting PRAME-positive tumor testing requirements * Metastatic or unresectable solid tumors * Have received (or be receiving), relapsed from, be refractory to or intolerant of all therapies * 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 * Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment * 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.