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New treatment option for Neoplasms
Official title Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT07276373
What this study is testing
What is Nenocorilant 200 mg?
Nenocorilant 200 mg is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for neoplasms.
Also referred to as CORT125236.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Has a life expectancy of ≥ 3 months
- Has evaluable disease based on RECIST v1.1
You likely can't join if
- 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...
- Grade ≥ 3
- 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
See the full eligibility 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
- 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:
- Grade ≥ 3
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Grand Rapids, Michigan, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Grand Rapids, Michigan, United States; San Antonio, Texas, United States; West Valley City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.