NCT07276373 Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
| NCT ID | NCT07276373 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Corcept Therapeutics |
| Condition | Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-01-16 |
| Primary Completion | 2026-09 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This open-label, dose-finding, and proof of concept study will evaluate the safety, tolerability, maximum-tolerated dose (MTD) and/or optimal dose of nenocorilant when administered in combination with nivolumab in patients with advanced solid malignancies.
Eligibility Criteria
Inclusion Criteria: Part 1 * Signed and dated institutional review board (IRB)/ independent ethics committee (IEC)-approved informed consent form (ICF) * Has solid malignancies that have received all available standard therapies for the specific tumor type or for which no standard therapy exists, unless patient is intolerant of treatment * Has a life expectancy of ≥ 3 months * Has evaluable disease based on RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has adequate organ function * Negative serum or urine pregnancy test for female patients of childbearing potential * Agreement to use appropriate precautions to avoid pregnancy, unless the patient and/or their sole sexual partner is permanently sterilized Exclusion Criteria: Part 1 * Past or current immune-related adverse events (irAEs) due to anti-programmed cell death protein 1 ligand 1 (PD\[L\]1) therapy that meet any of the following criteria: 1. Grade ≥ 3 2. Resulted in discontinuation of ant