Nenocorilant in Combination With Anti-Programmed Cell Death/(Ligand) 1 in Solid Tumors

What is the Purpose of this Study?

When cancers develop resistance to immunotherapy, tumors subsequently begin to grow. Cancer may use cortisol, a steroid hormone naturally produced in the body, to develop resistance to immunotherapy. Nenocorilant blocks the action of cortisol in the body and may help overcome resistance to immunotherapy. Nenocorilant will be given in combination with an immunotherapy drug called nivolumab. Nivolumab is approved by the U.S. Food and Drug Administration (FDA) to treat several types of cancer, but its use in combination with nenocorilant is experimental. Everyone who qualifies for the study will receive nenocorilant in combination with nivolumab; the dose of nenocorilant will depend upon which treatment group participants are assigned to. Researchers aim to determine the body’s response to and side effects of the study treatment, as well as the acceptable dose of nenocorilant in combination with nivolumab therapy. The study will also evaluate if and how the treatment may control the participant’s disease.

Eligibility

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

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

Show less

Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

What is the full name of this clinical trial?

CORT125236-750: A Phase 1b/2, Open-Label, Dose-Finding and Proof of Concept Study of Nenocorilant in Combination With Anti-Programmed Cell Death/ 1 in Patients With Advanced Solid Malignancies

Study Details

Disease Type/Condition

Breast, Colon, Esophagus, Kidney, Liver, Lung, Melanoma, Other Female Genital, Other Urinary, Ovary, Pancreas, Thyroid, Urinary Bladder

Principal Investigator

Hamid, Omid

Co-Investigators

Cathie T Chung, Inderjit Mehmi, Iryna Singh, Kristopher Wentzel

Age Group

Adult

Phase

I/II

IRB Number

STUDY00004585

ClinicalTrials.gov ID

NCT07276373

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org