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 groupsSponsors and collaborators
Source ClinicalTrials.gov