Health Trials

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

ConditionNeoplasms
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorcept Therapeutics

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nenocorilant 200 mg
  • Nenocorilant 300 mg
  • Nenocorilant 400 mg
  • Nivolumab

Treatment groups

50 Participants
are divided into 3 treatment groups

Locations

4
Site 0390025, Los AngelesCalifornia, United States
Site 0449546, Grand RapidsMichigan, United States
Site 0178229, San AntonioTexas, United States
Site 0284119, West Valley CityUtah, United States

Sponsors and collaborators

Corcept Therapeutics

Lead sponsor

Source ClinicalTrials.gov