NCT07276373

Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies

A Phase 1b/2, Open-Label, Dose-Finding and Proof of Concept Study of Nenocorilant in Combination With Anti-Programmed Cell Death/(Ligand) 1 in Patients With Advanced Solid Malignancies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1b/2 study that consists of 2 parts. In the dose-finding Phase 1b part, researchers will evaluate escalating dose levels of nenocorilant (given with a fixed dose and schedule of nivolumab) in patients with advanced solid malignancies. All patients will be treated with the combination of nenocorilant plus nivolumab in 28-day cycles. Nenocorilant will be administered orally once daily using a continuous dosing schedule, under fed conditions. Nivolumab will be initially given at 240 mg administered intravenously (IV) once every 2 weeks. After 3 months of treatment, patients may choose to switch to a fixed dosing regimen of 480 mg IV once every 4 weeks if they tolerate the combination regimen of nenocorilant plus nivolumab. The proof-of-concept Phase 2 part of this study is optional and may be added to further evaluate combination treatment in patients with advanced solid malignancies.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Nenocorilant 200 mg	Nenocorilant 200 mg will be supplied as 50 and/or 100 mg tablets.
DRUG	Nenocorilant 300 mg	Nenocorilant 300 mg will be supplied as 50 and/or 100 mg tablets.
DRUG	Nenocorilant 400 mg	Nenocorilant 400 mg will be supplied as 50 and/or 100 mg tablets.
DRUG	Nivolumab	Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials.

Timeline

• Start date: 2026-01-16
• Primary completion: 2026-09-01
• Completion: 2027-01-01
• First posted: 2025-12-11
• Last updated: 2026-04-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study