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

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.

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