NCT07276373 Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
| NCT ID | NCT07276373 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Corcept Therapeutics |
| Condition | Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-01-16 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-01-16 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Camille Renard
STUDY DIRECTOR
Corcept Therapeutics
Frequently Asked Questions
Who can join the NCT07276373 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07276373 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07276373 currently recruiting?
Yes, NCT07276373 is actively recruiting participants. Contact the research team at corceptstudy750@corcept.com for enrollment information.
Where is the NCT07276373 trial being conducted?
This trial is being conducted at Los Angeles, United States, Chicago, United States, Grand Rapids, United States, San Antonio, United States and 1 additional location.
Who is sponsoring the NCT07276373 clinical trial?
NCT07276373 is sponsored by Corcept Therapeutics. The principal investigator is Camille Renard at Corcept Therapeutics. The trial plans to enroll 50 participants.