Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07276373 | Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies | PHASE1 | RECRUITING | 50 | — | — | Jan 16, 2026 | Jan 1, 2027 | Apr 3, 2026 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1a: Nenocorilant 200 mg and Nivolumab | EXPERIMENTAL | Cohort 1a: Patients will receive nenocorilant 200 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated. |
| Cohort 1b: Nenocorilant 300 mg and Nivolumab | EXPERIMENTAL | Cohort 1b: Patients will receive nenocorilant 300 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated. |
| Cohort 1c: Nenocorilant 400 mg and Nivolumab | EXPERIMENTAL | Cohort 1c: Patients will receive nenocorilant 400 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated. |
| Name | Type | Description |
|---|---|---|
| Nenocorilant 200 mg | DRUG | Nenocorilant 200 mg will be supplied as 50 and/or 100 mg tablets. |
| Nenocorilant 300 mg | DRUG | Nenocorilant 300 mg will be supplied as 50 and/or 100 mg tablets. |
| Nenocorilant 400 mg | DRUG | Nenocorilant 400 mg will be supplied as 50 and/or 100 mg tablets. |
| Nivolumab | DRUG | Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials. |
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, ...