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

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 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

Conditions2

Locations3 sites

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