Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
Recruiting
Phase 1Phase 2Interventional Study
Neoplasms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Corcept Therapeutics · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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City
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Status
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, …
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
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