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

NCT ID: NCT07276373

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-16
• Study Completion Date: 2027-01-31

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1b: Nenocorilant 300 mg and Nivolumab

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.

Group Type: EXPERIMENTAL

Nenocorilant 300 mg

Intervention Type: DRUG

Nenocorilant 300 mg will be supplied as 50 and/or 100 mg tablets.

Nivolumab

Intervention Type: DRUG

Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials.

Cohort 1c: Nenocorilant 400 mg and Nivolumab

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.

Group Type: EXPERIMENTAL

Nenocorilant 400 mg

Intervention Type: DRUG

Nenocorilant 400 mg will be supplied as 50 and/or 100 mg tablets.

Nivolumab

Intervention Type: DRUG

Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials.

Cohort 1a: Nenocorilant 200 mg and Nivolumab

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.

Group Type: EXPERIMENTAL

Nenocorilant 200 mg

Intervention Type: DRUG

Nenocorilant 200 mg will be supplied as 50 and/or 100 mg tablets.

Nivolumab

Intervention Type: DRUG

Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials.

Interventions

Nenocorilant 200 mg

Nenocorilant 200 mg will be supplied as 50 and/or 100 mg tablets.

Intervention Type: DRUG

Nenocorilant 300 mg

Nenocorilant 300 mg will be supplied as 50 and/or 100 mg tablets.

Intervention Type: DRUG

Nenocorilant 400 mg

Nenocorilant 400 mg will be supplied as 50 and/or 100 mg tablets.

Intervention Type: DRUG

Nivolumab

Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials.

Intervention Type: DRUG

Other Intervention Names

CORT125236; CORT125236; CORT125236

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 anti-PD(L)1 therapy

• Medical history of an autoimmune or inflammatory disease requiring immunosuppressive therapy
• Medical history of adrenal insufficiency
• Has had any major surgery within 4 weeks prior to the first dose of study treatment
• Concurrent treatment with mifepristone or another glucocorticoid receptor (GR) modulator
• Unable to swallow, retain, or absorb oral medication
• Concurrent participation in another interventional clinical trial
• Has toxicities due to prior therapies that are reversible and have not resolved
• Requirement for treatment with prohibited medications, including but not limited to systemic corticosteroids and cytochrome P450(CYP)3A inducers or inhibitors
• Has a known history of severe hypersensitivity to any of the study drugs, or other human/humanized monoclonal antibodies
• Pregnant or lactating patients or female patients expecting to conceive children within the projected duration of the trial
• Has clinically significant uncontrolled condition(s) which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation
• Known psychiatric disorder that would interfere with trial compliance
• Has infection with HIV, hepatitis C virus, or hepatitis B virus
• Has untreated parenchymal brain metastasis or has uncontrolled central nervous system metastases
• Has a history of another malignancy within 2 years prior to study treatment, unless cured
• Has received prior autologous or allogeneic organ or tissue transplantation
• A QTcF interval >450 msec, a family history of long QT syndrome or unexplained sudden death at young age, or a requirement for use of medication that may prolong the QTc interval

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corcept Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Jubb, MD

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

Site 01

San Antonio, Texas, United States

Site Status: RECRUITING

Site 02

West Valley City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Corcept Therapeutics

Role: CONTACT

corceptstudy750@corcept.com

650-684-0171

Other Identifiers

CORT125236-750

Identifier Type: -

Identifier Source: org_study_id