[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578876":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":50,"studyPopulation":42,"armGroups":51,"interventions":70,"overallOfficials":82,"centralContacts":86,"locations":92,"responsibleParty":141,"collaborators":143,"id":147,"slug":42,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":42,"eligibilityCriteria":152,"healthyVolunteers":148,"sex":153,"minAge":154,"maxAge":42,"enrollmentInfo":155,"targetDuration":42,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":167,"overallStatus":95,"whyStopped":42,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"ORIC Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":42},[9,13,16,18],{"measure":10,"description":11,"timeFrame":12},"Recommended Phase 2 Dose (RP2D)","RP2D of ORIC-114 in combination with amivantamab by interval 3+3 dose escalation design","12 months",{"measure":14,"description":15,"timeFrame":12},"Objective response rate (ORR)","Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1",{"measure":17,"description":15,"timeFrame":12},"Duration of response (DOR)",{"measure":19,"description":15,"timeFrame":12},"Progression-free survival (PFS)",[21,25,27,29,31,34,36,38,40],{"measure":22,"description":23,"timeFrame":24},"Plasma PK parameters","Peak Plasma Concentration (Cmax)","28 Days",{"measure":22,"description":26,"timeFrame":24},"Time of maximal plasma concentration (Tmax)",{"measure":22,"description":28,"timeFrame":24},"Area under the plasma concentration vs time curve (AUC)",{"measure":22,"description":30,"timeFrame":24},"Apparent plasma terminal elimination half-life (t1\u002F2)",{"measure":32,"description":33,"timeFrame":12},"BICR-Objective response rate (ORR)","Blinded independent central review (BICR) according to RECIST 1.1 and RANO-BM",{"measure":35,"description":33,"timeFrame":12},"BICR-Duration of response (DOR)",{"measure":37,"description":33,"timeFrame":12},"BICR-Progression-free survival (PFS)",{"measure":39,"description":33,"timeFrame":12},"Intracranial Objective response rate (ORR)",{"measure":41,"description":33,"timeFrame":12},"Intracranial Progression-free survival (PFS)",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":42,"timePerspective":42,"maskingInfo":48},"NON_RANDOMIZED","SEQUENTIAL","Interval 3+3 dose escalation design followed by dose expansion","TREATMENT",{"masking":49,"maskingDescription":42,"whoMasked":42},"NONE","ORIC-114, is a brain penetrant, selective, orally bioavailable, irreversible small molecule inhibitor designed to target EGFR exon 20 insertion mutations, making it a promising therapeutic candidate for development in patients whose tumors harbor these alterations, including those with CNS metastases.\n\nAmivantamab is a bispecific EGFR-directed and MET receptor-directed antibody indicated in combination with carboplatin and pemetrexed for the first line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations and also as a single agent in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.\n\nThis is an open-label, single arm, multicenter, dose escalation followed by dose expansion study to assess the safety and preliminary antitumor activity of ORIC-114 in combination with SC amivantamab, in patients with locally advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutations.",[52,58,62,66],{"label":53,"type":54,"description":55,"interventionNames":56},"Part 1 Dose Escalation level 1","EXPERIMENTAL","ORIC-114 + amivantamab",[57],"Drug: ORIC-114 Dose 1 + amivantamab",{"label":59,"type":54,"description":55,"interventionNames":60},"Part 1 Dose Escalation level 2",[61],"Drug: ORIC-114 Dose 2 + amivantamab",{"label":63,"type":54,"description":55,"interventionNames":64},"Part 1 Dose Escalation level 3",[65],"Drug: ORIC-114 Dose 3 + amivantamab",{"label":67,"type":54,"description":68,"interventionNames":69},"Part 2 Dose Expansion","Two potential ORIC-114 dose levels + amivantamab",[61,65],[71,76,79],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":42},"DRUG","ORIC-114 Dose 1 + amivantamab","ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection",[53],{"type":72,"name":77,"description":74,"armGroupLabels":78,"otherNames":42},"ORIC-114 Dose 2 + amivantamab",[59,67],{"type":72,"name":80,"description":74,"armGroupLabels":81,"otherNames":42},"ORIC-114 Dose 3 + amivantamab",[63,67],[83],{"name":84,"affiliation":5,"role":85},"Pratik S. Multani, MD, MS","STUDY_DIRECTOR",[87],{"name":88,"role":89,"phone":90,"phoneExt":42,"email":91},"ORIC Clinical","CONTACT","650-388-5600","clinical@oricpharma.com",[93,106,116,129],{"facility":94,"status":95,"city":96,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":42},"NYU Langone Health","RECRUITING","New York","10016","United States","US",{"type":101,"coordinates":102},"Point",[103,104],-74.00597,40.71427,{"lat":104,"lon":103},{"facility":107,"status":95,"city":108,"state":109,"zip":110,"country":98,"countryCode":99,"cosmosGeoPoint":111,"geoPoint":115,"contacts":42},"Virginia Cancer Specialists","Fairfax","Virginia","22031",{"type":101,"coordinates":112},[113,114],-77.30637,38.84622,{"lat":114,"lon":113},{"facility":117,"status":118,"city":119,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":128,"contacts":42},"Peter MacCallum Cancer Centre","NOT_YET_RECRUITING","Melbourne","Victoria","03000","Australia","AU",{"type":101,"coordinates":125},[126,127],144.96332,-37.814,{"lat":127,"lon":126},{"facility":130,"status":118,"city":131,"state":132,"zip":133,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":42},"The Princess Margaret Hospital","Toronto","Ontario","M5G 1Z5","Canada","CA",{"type":101,"coordinates":137},[138,139],-79.39864,43.70643,{"lat":139,"lon":138},{"type":142,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[144],{"name":145,"class":146},"Janssen Research and Development LLC","UNKNOWN","100578876",false,"NCT06816992","ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC","Phase 1b Study of ORIC-114 in Combination With Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method; all tests should be performed in a CLIA certified or equivalently accredited laboratory\n* Prior Therapies:\n\n  1. Dose Escalation: Patients may have previously received and progressed on or after platinum-based chemotherapy or may be treatment naïve\n  2. Dose Expansion: Patients must not have received any prior therapy; at time of enrollment, patients must decline, or be ineligible for all available standard of care therapies with proven benefit\n* Agreement and ability to undergo a pretreatment biopsy, provided the procedure is clinically feasible and not deemed unsafe by the investigator\n* Measurable disease according to RECIST 1.1\n* Patients with asymptomatic CNS metastases are eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known small cell lung cancer transformation\n* Leptomeningeal disease\n* Spinal cord compression not definitively treated with surgery or radiation\n* Prior immunotherapy\n* Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD\n* Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact absorption of ORIC-114","ALL","18 Years",{"count":156,"type":157},76,"ESTIMATED","INTERVENTIONAL",[160],"PHASE1","The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.",[163,164,165,166],"Solid Tumors","EGFR Exon 20 Insertion Mutations","NSCLC","EGFR-mutated NSCLC",[165,168,169,170,171,172],"EGFR mutations","EGFR exon20","EGFR exon 20 insertion mutations","ORIC-114","Amivantamab","2026-04-21",{"date":175,"type":176},"2026-04-24","ACTUAL",{"date":178,"type":176},"2025-02-27",{"date":180,"type":157},"2027-12",{"name":5,"class":6},4]