[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07276373":3,"trial-entities:NCT07276373":187,"trial-summary:NCT07276373":191},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":29,"interventions":32,"primary_outcomes":57,"secondary_outcomes":69,"sex":98,"minimum_age":99,"maximum_age":100,"healthy_volunteers":15,"eligibility_criteria":101,"std_ages":131,"locations":134,"central_contacts":176,"overall_officials":181,"references":185,"see_also_links":186},"NCT07276373","CORT125236-750","Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies","A Phase 1b\u002F2, Open-Label, Dose-Finding and Proof of Concept Study of Nenocorilant in Combination With Anti-Programmed Cell Death\u002F(Ligand) 1 in Patients With Advanced Solid Malignancies","RECRUITING","2027-01","2026-08","2026-08-19","2026-01-16","Corcept Therapeutics","INDUSTRY",false,"This open-label, dose-finding, and proof of concept study will evaluate the safety, tolerability, maximum-tolerated dose (MTD) and\u002For optimal dose of nenocorilant when administered in combination with nivolumab in patients with advanced solid malignancies.","This is a Phase 1b\u002F2 study that consists of 2 parts.\n\nIn 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.\n\nThe 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.",[19],"Neoplasms",[21,22,23],"Advanced Solid Tumors","Solid Tumors","Solid Malignancies","INTERVENTIONAL","TREATMENT",[27,28],"PHASE1","PHASE2",{"count":30,"type":31},50,"ESTIMATED",[33,41,47,53],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","Nenocorilant 200 mg","Nenocorilant 200 mg will be supplied as 50 and\u002For 100 mg tablets.",[38],"Cohort 1a: Nenocorilant 200 mg and Nivolumab",[40],"CORT125236",{"type":34,"name":42,"description":43,"armGroupLabels":44,"otherNames":46},"Nenocorilant 300 mg","Nenocorilant 300 mg will be supplied as 50 and\u002For 100 mg tablets.",[45],"Cohort 1b: Nenocorilant 300 mg and Nivolumab",[40],{"type":34,"name":48,"description":49,"armGroupLabels":50,"otherNames":52},"Nenocorilant 400 mg","Nenocorilant 400 mg will be supplied as 50 and\u002For 100 mg tablets.",[51],"Cohort 1c: Nenocorilant 400 mg and Nivolumab",[40],{"type":34,"name":54,"description":55,"armGroupLabels":56},"Nivolumab","Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg\u002F12 mL (10 mg\u002FmL) vials.",[38,45,51],[58,61,63,66],{"measure":59,"timeFrame":60},"Number of Patients With 1 or More Adverse Event","From first dose of study treatment up to 28 days after final dose, assessed up to 9 months",{"measure":62,"timeFrame":60},"Number of Patients With 1 or More Serious Adverse Events",{"measure":64,"timeFrame":65},"Number of Patients With 1 or More Adverse Events Leading to Study Drug Discontinuation","From first dose of study treatment up to final dose, assessed up to 9 months",{"measure":67,"timeFrame":68},"Percent of Patients who Experience Dose Limiting Toxicity (DLT)","Up to 28 days after initiation of Cycle 1 (each cycle consists of 28 days)",[70,74,78,82,86,90,93,96],{"measure":71,"description":72,"timeFrame":73},"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).","From date of first dose to progressive disease (PD)\u002Fconfirmed 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",{"measure":75,"description":76,"timeFrame":77},"Duration of Response (DoR)","To evaluate DoR as the time from the first CR or PR to first documented PD\u002FiCPD or death or start of non-protocol-specified new anticancer therapy, whichever occurs first.","Time of first objective response until PD\u002FiCPD or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months",{"measure":79,"description":80,"timeFrame":81},"Best Overall Response (BOR)","To evaluate BOR as the proportion of patients with a BOR of CR, PR, stable disease (SD), PD, or nonevaluable.","From first dose until PD\u002FiCPD or death or start of non-protocol-specified anticancer therapy, assessed up to 8 months",{"measure":83,"description":84,"timeFrame":85},"Duration of SD","To evaluate duration of SD as defined as the time from the start of combination treatment until the criteria for PD\u002FiCPD are met.","Date of start of combined treatment until the criteria for PD\u002FiCPD are met, assessed up to 8 months",{"measure":87,"description":88,"timeFrame":89},"Progression-Free Survival (PFS)","To evaluate progression-free survival as the time from the first dose of nenocorilant until PD\u002FiCPD or death or start of non-protocol-specified new anticancer therapy, whichever occurs first.","Date of first dose until PD\u002FiCPD or death or start of non-protocol-specified new anticancer therapy, assessed up to 8 months",{"measure":91,"timeFrame":92},"Change from Baseline of Fridericia-Corrected QT (QTcF) Interval","Baseline to End of Treatment, assessed up to 8 months",{"measure":94,"timeFrame":95},"Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Nenocorilant","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)",{"measure":97,"timeFrame":95},"Maximum Observed Plasma Concentration (Cmax) of Nenocorilant","ALL","18 Years",null,{"inclusion":102,"exclusion":111,"raw_text":130},[103,104,105,106,107,108,109,110],"Signed and dated institutional review board (IRB)\u002F 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\u002For their sole sexual partner is permanently sterilized",[112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129],"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","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\u002Fhumanized 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","Inclusion Criteria:\n\nPart 1\n\n* Signed and dated institutional review board (IRB)\u002F independent ethics committee (IEC)-approved informed consent form (ICF)\n* 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\n* Has a life expectancy of ≥ 3 months\n* Has evaluable disease based on RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Has adequate organ function\n* Negative serum or urine pregnancy test for female patients of childbearing potential\n* Agreement to use appropriate precautions to avoid pregnancy, unless the patient and\u002For their sole sexual partner is permanently sterilized\n\nExclusion Criteria:\n\nPart 1\n\n* 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:\n\n  1. Grade ≥ 3\n  2. Resulted in discontinuation of anti-PD(L)1 therapy\n* Medical history of an autoimmune or inflammatory disease requiring immunosuppressive therapy\n* Medical history of adrenal insufficiency\n* Has had any major surgery within 4 weeks prior to the first dose of study treatment\n* Concurrent treatment with mifepristone or another glucocorticoid receptor (GR) modulator\n* Unable to swallow, retain, or absorb oral medication\n* Concurrent participation in another interventional clinical trial\n* Has toxicities due to prior therapies that are reversible and have not resolved\n* Requirement for treatment with prohibited medications, including but not limited to systemic corticosteroids and cytochrome P450(CYP)3A inducers or inhibitors\n* Has a known history of severe hypersensitivity to any of the study drugs, or other human\u002Fhumanized monoclonal antibodies\n* Pregnant or lactating patients or female patients expecting to conceive children within the projected duration of the trial\n* 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\n* Known psychiatric disorder that would interfere with trial compliance\n* Has infection with HIV, hepatitis C virus, or hepatitis B virus\n* Has untreated parenchymal brain metastasis or has uncontrolled central nervous system metastases\n* Has a history of another malignancy within 2 years prior to study treatment, unless cured\n* Has received prior autologous or allogeneic organ or tissue transplantation\n* 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",[132,133],"ADULT","OLDER_ADULT",[135,144,152,160,168],{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":140,"geoPoint":141},"Site 03","Los Angeles","California","90025","United States",{"lat":142,"lon":143},34.05223,-118.24368,{"facility":145,"status":8,"city":146,"state":147,"zip":148,"country":140,"geoPoint":149},"Site 05","Chicago","Illinois","60637",{"lat":150,"lon":151},41.85003,-87.65005,{"facility":153,"status":8,"city":154,"state":155,"zip":156,"country":140,"geoPoint":157},"Site 04","Grand Rapids","Michigan","49546",{"lat":158,"lon":159},42.96336,-85.66809,{"facility":161,"status":8,"city":162,"state":163,"zip":164,"country":140,"geoPoint":165},"Site 01","San Antonio","Texas","78229",{"lat":166,"lon":167},29.42412,-98.49363,{"facility":169,"status":8,"city":170,"state":171,"zip":172,"country":140,"geoPoint":173},"Site 02","West Valley City","Utah","84119",{"lat":174,"lon":175},40.69161,-112.00105,[177],{"name":13,"role":178,"phone":179,"email":180},"CONTACT","(669) 251-7034","corceptstudy750@corcept.com",[182],{"name":183,"affiliation":13,"role":184},"Camille Renard","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":188,"biomarkers":190},[189],"Solid Neoplasm",[],{"nct_id":4,"found":192,"summary":193,"prompt_version":203},true,{"design":194,"status":195,"heading":196,"summary":197,"follow_up":198,"word_count":199,"commitments":200,"compensation":201,"drugs_mentioned":202},"This is an open-label, two-part study (Phase 1b\u002F2) that will enroll about 50 participants. It is designed to find the right dose of nenocorilant when combined with nivolumab.","completed","Study of Nenocorilant with Nivolumab for Advanced Solid Cancers","This study is testing a new combination of two drugs, nenocorilant and nivolumab, for people with advanced solid cancers. You might be able to join if your cancer has already been treated with standard therapies, or if there are no standard treatments available. Researchers want to find the safest and most effective dose of nenocorilant when given with nivolumab. They will be watching closely for any side effects (adverse events) that happen during the study. This is an open-label study, meaning both you and your doctors will know which treatments you are receiving. The study aims to enroll about 50 participants.","Researchers will track any side effects for up to 28 days after your last dose of study treatment, and assess them for up to 9 months.",101,"You would take nenocorilant by mouth once daily and receive nivolumab intravenously (through a vein) every 2 or 4 weeks. This treatment would be given in 28-day cycles.","Not stated in the trial record.",[54],"v2"]