NeoplasmsPhase 1/2NCT07276373
Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
A Phase 1/2 study testing Nenocorilant 200 mg, Nenocorilant 300 mg and Nenocorilant 400 mg in people with Neoplasms, run by Corcept Therapeutics at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Nenocorilant 200 mg, Nenocorilant 300 mg and Nenocorilant 400 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Jan 2026to Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Site 05
Chicago, Illinois, 60637
- Recruiting
Site 04
Grand Rapids, Michigan, 49546
- Recruiting
Site 03
Los Angeles, California, 90025
- Recruiting
Site 01
San Antonio, Texas, 78229
- Recruiting
Site 02
West Valley City, Utah, 84119
About this study
Official title: A Phase 1b/2, 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
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.
Read the detailed description
This is a Phase 1b/2 study that consists of 2 parts.
In the dose-finding Phase 1b part, researchers will evaluate escalating dose levels of nenocorilant (given with a fixed dose and schedule of nivolumab) in patients with advanced solid malignancies. All patients will be treated with the combination of nenocorilant plus nivolumab in 28-day cycles. Nenocorilant will be administered orally once daily using a continuous dosing schedule, under fed conditions. Nivolumab will be initially given at 240 mg administered intravenously (IV) once every 2 weeks. After 3 months of treatment, patients may choose to switch to a fixed dosing regimen of 480 mg IV once every 4 weeks if they tolerate the combination regimen of nenocorilant plus nivolumab.
The proof-of-concept Phase 2 part of this study is optional and may be added to further evaluate combination treatment in patients with advanced solid malignancies.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nenocorilant 200 mgDrug
Also called CORT125236
Nenocorilant 200 mg will be supplied as 50 and/or 100 mg tablets.
Nenocorilant 300 mgDrug
Also called CORT125236
Nenocorilant 300 mg will be supplied as 50 and/or 100 mg tablets.
Nenocorilant 400 mgDrug
Also called CORT125236
Nenocorilant 400 mg will be supplied as 50 and/or 100 mg tablets.
NivolumabDrug
Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a: Nenocorilant 200 mg and Nivolumab | Experimental | 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. Receives: Drug: Nenocorilant 200 mg; Drug: Nivolumab |
| Cohort 1b: Nenocorilant 300 mg and Nivolumab | Experimental | 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. Receives: Drug: Nenocorilant 300 mg; Drug: Nivolumab |
| Cohort 1c: Nenocorilant 400 mg and Nivolumab | Experimental | 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. Receives: Drug: Nenocorilant 400 mg; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With 1 or More Adverse Event
Measured: From first dose of study treatment up to 28 days after final dose, assessed up to 9 months
Number of Patients With 1 or More Serious Adverse Events
Measured: From first dose of study treatment up to 28 days after final dose, assessed up to 9 months
Number of Patients With 1 or More Adverse Events Leading to Study Drug Discontinuation
Measured: From first dose of study treatment up to final dose, assessed up to 9 months
Percent of Patients who Experience Dose Limiting Toxicity (DLT)
Measured: Up to 28 days after initiation of Cycle 1 (each cycle consists of 28 days)
Secondary outcomes (8)
Objective Response Rate (ORR)
To evaluate the proportion of patients with measurable disease at baseline who attain a confirmed complete response (CR) or partial response (PR).
Measured: From date of first dose to progressive disease (PD)/confirmed PD using immune Response Evaluation Criteria in Solid Tumors (iRECIST) (iCPD) or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months
Duration of Response (DoR)
To evaluate DoR as the time from the first CR or PR to first documented PD/iCPD or death or start of non-protocol-specified new anticancer therapy, whichever occurs first.
Measured: Time of first objective response until PD/iCPD or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months
Best Overall Response (BOR)
To evaluate BOR as the proportion of patients with a BOR of CR, PR, stable disease (SD), PD, or nonevaluable.
Measured: From first dose until PD/iCPD or death or start of non-protocol-specified anticancer therapy, assessed up to 8 months
Duration of SD
To evaluate duration of SD as defined as the time from the start of combination treatment until the criteria for PD/iCPD are met.
Measured: Date of start of combined treatment until the criteria for PD/iCPD are met, assessed up to 8 months
Progression-Free Survival (PFS)
To evaluate progression-free survival as the time from the first dose of nenocorilant until PD/iCPD or death or start of non-protocol-specified new anticancer therapy, whichever occurs first.
Measured: Date of first dose until PD/iCPD or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months
Change from Baseline of Fridericia-Corrected QT (QTcF) Interval
Measured: Baseline to End of Treatment, assessed up to 8 months
Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Nenocorilant
Measured: Cycle 1 Day 15 predose and 1, 2, 3, 4, and 6 hours postdose and Cycle 2 Day 1 predose (each cycle consists of 28 days)
Maximum Observed Plasma Concentration (Cmax) of Nenocorilant
Measured: Cycle 1 Day 15 predose and 1, 2, 3, 4, and 6 hours postdose and Cycle 2 Day 1 predose (each cycle consists of 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start16 Jan 2026
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Camille Renard, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276373
- Sponsor's protocol ID
- CORT125236-750
- Status last verified
- Aug 2026
- First submitted
- 1 Dec 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, 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
- ClinicalTrials.gov ID
- NCT07276373
- Acronym / sponsor ID
- CORT125236-750
- Conditions
- Neoplasms
- Keywords
- Advanced Solid Tumors, Solid Tumors, Solid Malignancies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1b/2 study that consists of 2 parts.
In the dose-finding Phase 1b part, researchers will evaluate escalating dose levels of nenocorilant (given with a fixed dose and schedule of nivolumab) in patients with advanced solid malignancies. All patients will be treated with the combination of nenocorilant plus nivolumab in 28-day cycles. Nenocorilant will be administered orally once daily using a continuous dosing schedule, under fed conditions. Nivolumab will be initially given at 240 mg administered intravenously (IV) once every 2 weeks. After 3 months of treatment, patients may choose to switch to a fixed dosing regimen of 480 mg IV once every 4 weeks if they tolerate the combination regimen of nenocorilant plus nivolumab.
The proof-of-concept Phase 2 part of this study is optional and may be added to further evaluate combination treatment in patients with advanced solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a: Nenocorilant 200 mg and Nivolumab | Experimental | Drug: Nenocorilant 200 mg, Drug: NivolumabCohort 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. |
| Cohort 1b: Nenocorilant 300 mg and Nivolumab | Experimental | Drug: Nenocorilant 300 mg, Drug: NivolumabCohort 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. |
| Cohort 1c: Nenocorilant 400 mg and Nivolumab | Experimental | Drug: Nenocorilant 400 mg, Drug: NivolumabCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nenocorilant 200 mgAlso: CORT125236Nenocorilant 200 mg will be supplied as 50 and/or 100 mg tablets. | Drug | Cohort 1a: Nenocorilant 200 mg and Nivolumab |
| Nenocorilant 300 mgAlso: CORT125236Nenocorilant 300 mg will be supplied as 50 and/or 100 mg tablets. | Drug | Cohort 1b: Nenocorilant 300 mg and Nivolumab |
| Nenocorilant 400 mgAlso: CORT125236Nenocorilant 400 mg will be supplied as 50 and/or 100 mg tablets. | Drug | Cohort 1c: Nenocorilant 400 mg and Nivolumab |
| NivolumabNivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials. | Drug | Cohort 1a: Nenocorilant 200 mg and Nivolumab, Cohort 1b: Nenocorilant 300 mg and Nivolumab, Cohort 1c: Nenocorilant 400 mg and Nivolumab |
Primary outcome
Number of Patients With 1 or More Adverse Event
Time frame: From first dose of study treatment up to 28 days after final dose, assessed up to 9 months
Number of Patients With 1 or More Serious Adverse Events
Time frame: From first dose of study treatment up to 28 days after final dose, assessed up to 9 months
Number of Patients With 1 or More Adverse Events Leading to Study Drug Discontinuation
Time frame: From first dose of study treatment up to final dose, assessed up to 9 months
Percent of Patients who Experience Dose Limiting Toxicity (DLT)
Time frame: Up to 28 days after initiation of Cycle 1 (each cycle consists of 28 days)
8 secondary outcomes
Objective Response Rate (ORR)
Time frame: From date of first dose to progressive disease (PD)/confirmed PD using immune Response Evaluation Criteria in Solid Tumors (iRECIST) (iCPD) or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months
Duration of Response (DoR)
Time frame: Time of first objective response until PD/iCPD or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months
Best Overall Response (BOR)
Time frame: From first dose until PD/iCPD or death or start of non-protocol-specified anticancer therapy, assessed up to 8 months
Duration of SD
Time frame: Date of start of combined treatment until the criteria for PD/iCPD are met, assessed up to 8 months
Progression-Free Survival (PFS)
Time frame: Date of first dose until PD/iCPD or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months
Change from Baseline of Fridericia-Corrected QT (QTcF) Interval
Time frame: Baseline to End of Treatment, assessed up to 8 months
Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Nenocorilant
Time frame: Cycle 1 Day 15 predose and 1, 2, 3, 4, and 6 hours postdose and Cycle 2 Day 1 predose (each cycle consists of 28 days)
Maximum Observed Plasma Concentration (Cmax) of Nenocorilant
Time frame: Cycle 1 Day 15 predose and 1, 2, 3, 4, and 6 hours postdose and Cycle 2 Day 1 predose (each cycle consists of 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camille Renard study director
Corcept Therapeutics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nenocorilant 200 mg, Nenocorilant 300 mg and Nenocorilant 400 mg in people with Neoplasms, run by Corcept Therapeutics at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corcept Therapeutics ((669) 251-7034, corceptstudy750@corcept.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With 1 or More Adverse Event (time frame: From first dose of study treatment up to 28 days after final dose, assessed up to 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.