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

NCT07276373 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CORT125236-750
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Neoplasms

Keywords

Advanced Solid Tumors; Solid Tumors; Solid Malignancies

Outcome Measures

Primary Outcomes (4)

• Number of Patients With 1 or More Adverse Event

  From first dose of study treatment up to 28 days after final dose, assessed up to 9 months

• Number of Patients With 1 or More Serious Adverse Events

  From first dose of study treatment up to 28 days after final dose, assessed up to 9 months

• Number of Patients With 1 or More Adverse Events Leading to Study Drug Discontinuation

  From first dose of study treatment up to final dose, assessed up to 9 months

• Percent of Patients who Experience Dose Limiting Toxicity (DLT)

  Up to 28 days after initiation of Cycle 1 (each cycle consists of 28 days)

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  From date of first dose to progressive disease (PD)/confirmed PD using immune Response Evaluation Criteria in Solid Tumors (iRECIST) (iCPD) or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months

• Duration of Response (DoR)

  Time of first objective response until PD/iCPD or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months

• Best Overall Response (BOR)

  From first dose until PD/iCPD or death or start of non-protocol-specified anticancer therapy, assessed up to 8 months

• Duration of SD

  Date of start of combined treatment until the criteria for PD/iCPD are met, assessed up to 8 months

• Progression-Free Survival (PFS)

  Date of first dose until PD/iCPD or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months

Study Arms (3)

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.

Drug: Nenocorilant 200 mg; Drug: Nivolumab

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.

Drug: Nenocorilant 300 mg; Drug: Nivolumab

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.

Drug: Nenocorilant 400 mg; Drug: Nivolumab

Interventions

Nenocorilant 200 mg DRUG

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

Also known as: CORT125236

Cohort 1a: Nenocorilant 200 mg and Nivolumab

Nenocorilant 300 mg DRUG

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

Also known as: CORT125236

Cohort 1b: Nenocorilant 300 mg and Nivolumab

Nenocorilant 400 mg DRUG

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

Also known as: CORT125236

Cohort 1c: Nenocorilant 400 mg and Nivolumab

Nivolumab 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 1b: Nenocorilant 300 mg and Nivolumab; Cohort 1c: Nenocorilant 400 mg and Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Grade ≥ 3
• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (3)

Site 03

Los Angeles, California, 90025, United States

RECRUITING

Site 01

San Antonio, Texas, 78229, United States

RECRUITING

Site 02

West Valley City, Utah, 84119, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Adrian Jubb, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Corcept Therapeutics

CONTACT

650-684-0171; corceptstudy750@corcept.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 11, 2025
• Study Start: January 16, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)