A Phase Ib/II, Open-Label, Dose-Finding and Proof of Concept Study of Nenocorilant in Combination With Anti-Programmed Cell Death/(Ligand) 1 in Patients With Advanced Solid Malignancies

Study Identifier:
CORT125236-750
CT.gov Identifier:
NCT07276373
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Unspecified Cancer
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Cohort 1a: Nenocorilant 200 mg and Nivolumab
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Drug: Cohort 1a: Patients will receive nenocorilant 200 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated.
Drug: Drug: Nenocorilant 200 mg
Drug: Nenocorilant 200 mg will be supplied as 50 and/or 100 mg tablets.
Drug: Other Names: CORT125236
Drug: Drug: Nivolumab
Drug: Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials.
Drug: EXPERIMENTAL: Cohort 1b: Nenocorilant 300 mg and Nivolumab
Drug: Cohort 1b: Patients will receive nenocorilant 300 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated.
Drug: Drug: Nenocorilant 300 mg
Drug: Nenocorilant 300 mg will be supplied as 50 and/or 100 mg tablets.
Drug: EXPERIMENTAL: Cohort 1c: Nenocorilant 400 mg and Nivolumab
Drug: Cohort 1c: Patients will receive nenocorilant 400 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated.
Drug: Drug: Nenocorilant 400 mg
Drug: Nenocorilant 400 mg will be supplied as 50 and/or 100 mg tablets.
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Sreenivasa Chandana
Status
Recruiting
Condition(s) Treated at Site
Unspecified Cancer
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Jose Pacheco
Status
Recruiting
Condition(s) Treated at Site
Unspecified Cancer
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Drew Rasco
Status
Recruiting
Condition(s) Treated at Site
Unspecified Cancer