Recruiting
Phase 1
Phase 2

Nenocorilant & Nivolumab

Sponsor:

Corcept Therapeutics

Code:

NCT07276373

Conditions

Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nenocorilant 200 mg

Nenocorilant 300 mg

Nenocorilant 400 mg

Nivolumab

Study Details

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

Study ID

NCT07276373

Start date

Jan 16, 2026

Status verified date

Aug, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

Nenocorilant 200 mg

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

Nenocorilant 300 mg

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

Nenocorilant 400 mg

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

Nivolumab

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

Primary outcome measure

  • Number of Patients With 1 or More Adverse Event [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From first dose of study treatment up to final dose, assessed up to 9 months ]
  • Percent of Patients who Experience Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 days after initiation of Cycle 1 (each cycle consists of 28 days) ]

Central Contacts and Locations

Central contacts

Corcept Therapeutics

(669) 251-7034corceptstudy750@corcept.com

Locations

Site 03

Recruiting

Los Angeles, California, United States, 90025

Site 05

Recruiting

Chicago, Illinois, United States, 60637

Site 04

Recruiting

Grand Rapids, Michigan, United States, 49546

Site 01

Recruiting

San Antonio, Texas, United States, 78229

Site 02

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

Corcept Therapeutics

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Advanced Solid Tumors
  • Solid Tumors
  • Solid Malignancies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Corcept Therapeutics on 2026-08-19.