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Clinical Trials in the USA / NCT07276373
Recruiting Phase 1/2

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

NCT07276373 · tracked via the Priya Life Science USA tracker
Sponsor
Corcept Therapeutics
Phase
Phase 1/2
Started
2026-01-16
Last updated
2026-08-19

Condition(s) studied

Neoplasms

Investigational drug(s) / intervention(s)

Nenocorilant 200 mgNenocorilant 300 mgNenocorilant 400 mgNivolumab

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Site 03 Los Angeles California Recruiting
Site 05 Chicago Illinois Recruiting
Site 04 Grand Rapids Michigan Recruiting
Site 01 San Antonio Texas Recruiting
Site 02 West Valley City Utah Recruiting

On this site

📄 Opdivo (nivolumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07276373 on ClinicalTrials.gov ↗ ← All trials in the USA