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Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
RecruitingPhase 1, Phase 2
Sponsor: Corcept Therapeutics
Conditions: Neoplasms
Interventions: Nenocorilant 200 mg, Nenocorilant 300 mg, Nenocorilant 400 mg, Nivolumab
Countries: United States
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 overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
Locations (5)
- Los Angeles, California, United States
- Chicago, Illinois, United States
- Grand Rapids, Michigan, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States