Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies

Part of paid clinical trials in Los Angeles, California.

Sponsor
Corcept Therapeutics
Study ID
NCT07276373
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nenocorilant 200 mg — DRUG
    Nenocorilant 200 mg will be supplied as 50 and/or 100 mg tablets.
  • Nenocorilant 300 mg — DRUG
    Nenocorilant 300 mg will be supplied as 50 and/or 100 mg tablets.
  • Nenocorilant 400 mg — DRUG
    Nenocorilant 400 mg will be supplied as 50 and/or 100 mg tablets.
  • Nivolumab — DRUG
    Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg/12 mL (10 mg/mL) vials.

Study Details

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.

Key Dates

Start date
Jan 16, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1a: Nenocorilant 200 mg and Nivolumab
    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.
  • Experimental: Cohort 1b: Nenocorilant 300 mg and Nivolumab
    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.
  • Experimental: Cohort 1c: Nenocorilant 400 mg and Nivolumab
    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.

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 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Site 03Los AngelesCalifornia90025-
Site 04Grand RapidsMichigan49546-
Site 01San AntonioTexas78229-
Site 02West Valley CityUtah84119-

Find similar trials in Los Angeles, CA

By research site
Site 03· Los Angeles, CASite 04· Grand Rapids, MISite 01· San Antonio, TXSite 02· West Valley City, UT

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