Corcept Therapeutics, CORT125236-750, Ph 1b/2, Nenocorilant in Combo w Nivo, Adv Solid Malignancies

What is the Purpose of this Study?

Dose-Finding Phase 1b - Part 1 Primary Objectives: To evaluate the safety and tolerability of nenocorilant in combination with nivolumab in patients with advanced solid malignancies. To determine the maximum tolerated dose (MTD) and/or the optimal dose/schedule of nenocorilant when given in combination with nivolumab for further evaluation in patients with advanced solid malignancies. Secondary Objectives: Secondary Efficacy Objectives by Response Evaluation Criteria in Solid Tumors (RECIST) (Eisenhauer 2009) and immune RECIST (iRECIST) (Seymour 2017) as Assessed by the Investigator − Objective response rate − Duration of response − Best overall response − Duration of stable disease − Progression-free survival Secondary Safety Objective − To evaluate the impact of nenocorilant on the Fridericia-corrected QT interval (QTcF) interval. Pharmacokinetic Objective − To assess the steady state pharmacokinetics (PK) of nenocorilant. Exploratory Objectives: To evaluate the pharmacodynamic effects of nenocorilant and nivolumab. To explore the relationship between baseline biomarkers and pharmacodynamic biomarkers with treatment response. Phase 2 - Part 2 The primary objective of Part 2 is to evaluate the preliminary efficacy and safety of the optimal dose/schedule of nenocorilant determined in the Dose-Finding Phase 1b in patients with advanced solid malignancies, when given in combination with nivolumab. This protocol will be amended to include the detailed Phase 2 study design.

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

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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?

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, Justin Moyers, 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