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
Corcept Therapeutics
50 participants
Jan 16, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria21
- 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
- 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
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Interventions
Nenocorilant 200 mg will be supplied as 50 and/or 100 mg tablets.
Nenocorilant 300 mg will be supplied as 50 and/or 100 mg tablets.
Nenocorilant 400 mg will be supplied as 50 and/or 100 mg tablets.
Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07276373