[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ORIC Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100578876","phase-1-oric-114-in-combination-with-subcutaneous-amivantamab-in-patients-with-egfr-exon20-insertion-mutant-nsclc-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":19,"type":20},76,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29],"Solid Tumors","EGFR Exon 20 Insertion Mutations","NSCLC","EGFR-mutated NSCLC",[28,31,32,33,34,35],"EGFR mutations","EGFR exon20","EGFR exon 20 insertion mutations","ORIC-114","Amivantamab","RECRUITING","2026-04-21",{"date":39,"type":40},"2026-04-24","ACTUAL",{"date":42,"type":40},"2025-02-27",{"date":44,"type":20},"2027-12",{"name":46,"class":47},"ORIC Pharmaceuticals","INDUSTRY",4,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100471019","phase-1-study-of-oric-944-in-patients-with-metastatic-prostate-cancer-100471019","NCT05413421","Study of ORIC-944 in Patients With Metastatic Prostate Cancer","An Open-Label, Phase 1\u002F1b Study of ORIC-944 as a Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer","Inclusion Criteria:\n\n* Patients with metastatic prostate cancer\n* Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone\n* Prior therapies:\n\nPart I (single agent ORIC-944 dose escalation): Any number of prior therapies are allowed, but must have progressed after at least one line of next generation ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) and must not have received more than 2 chemotherapy regimens in the mCRPC setting\n\nPart II (ARPI combination dose escalation): Must have received only 1 prior line of ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in any setting; may have also received up to 1 prior line of chemotherapy in the mCSPC setting\n\nPart III (ARPI combination dose optimization): In addition to up to 1 prior line of chemotherapy in the mCSPC setting:\n\n* Cohorts A and B: received only one 1 prior line of abiraterone in any setting\n* Cohorts C and D: received only one 1 prior line of apalutamide, darolutamide, or enzalutamide in any setting:\n\n  * Evidence of progressive disease by PCWG3 criteria for study entry\n\n    * rising PSA, defined as a minimum of 2 rising values obtained a minimum of one week apart with the latest result being at least 2.0 ng\u002FmL (or 1.0 ng\u002FmL if PSA rise is the only indication of progression), or\n    * confirmation of 2 new bone lesions on last systemic therapy, or\n    * soft tissue progression per RECIST 1.1\n  * Measurable and\u002For evaluable disease by RECIST 1.1\n  * Agreement and ability to undergo on-study punch skin biopsies and core tumor biopsies\n  * ECOG performance status of 0 or 1\n  * Adequate organ function\n\nExclusion Criteria:\n\n* History or presence of CNS metastases, unless previously treated and stable\n* History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months\n* Known, symptomatic human immunodeficiency virus (HIV) infection\n* Active symptomatic Hepatitis B or C infection; patients with well controlled disease are eligible\n* Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, short gut syndrome, etc) or other malabsorption syndromes that would reasonably impact drug absorption per investigator judgement\n* Any other condition or circumstance (eg, clinical, psychological, familial, sociological, inability to swallow oral study drug) that, in the opinion of the investigator, may interfere with protocol compliance or contraindicates participation in the study","MALE",{"count":58,"type":20},250,[23],"The purpose of this study is to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combinations with ARPIs in patients with metastatic prostate cancer.",[62],"Metastatic Prostate Cancer",[64,65,66,67,68],"PRC2 dysregulation","EED","CRPC","mCRPC","ARPI","2025-08-06",{"date":71,"type":40},"2025-08-11",{"date":73,"type":40},"2022-06-01",{"date":75,"type":20},"2026-09",{"name":46,"class":47},27,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100463515","phase-1-study-of-oric-114-in-patients-with-advanced-solid-tumors-harboring-an-egfr-or-her2-alteration-100463515","NCT05315700","Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration","An Open-Label, Phase 1\u002F2 Study of ORIC-114 as a Single Agent or in Combination With Chemotherapy, in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented EGFR or HER2 exon 20 insertion mutation or atypical EGFR mutation as determined by any nucleic acid-based diagnostic testing method, or HER2 amplification\u002Foverexpression as determined by an immunohistochemistry (IHC) or an in situ hybridization (ISH) test\n\n  1. Part I Dose Escalation (CLOSED) Any solid tumor with\n\n     * EGFR exon 20 insertion mutation\n     * HER2 exon 20 insertion mutation\n     * Atypical EGFR mutations (NSCLC only) (Appendix 8)\n     * HER2 amplification or overexpression (HER2+)\n     * Previously received and progressed on or after available standard therapies and for whom additional standard therapy is considered unsuitable or intolerable\n  2. Part I Extension (ONGOING)\n\n     * Cohort IA: Patients with HER2+ breast cancer previously received and progressed on or after available standard therapies and for whom additional standard therapy is considered unsuitable or intolerable\n     * Cohort IB: NSCLC patients with EGFR exon 20 insertion mutation previously treated with chemotherapy and amivantamab\n     * Cohort IC: Treatment-naïve NSCLC patients with EGFR exon 20 insertion mutation\n     * Cohort ID: Treatment-naïve NSCLC patients with EGFR atypical mutations\n  3. Part II Dose Optimization (ONGOING): NSCLC patients with\n\n     * Cohort IIA: EGFR exon 20 insertion mutation, patients must have received platinum-based chemotherapy or other chemotherapy regimen if platinum- based chemotherapy was contraindicated. Additionally, patients must be naïve to an EGFR exon 20 targeted agent, ie, must have declined or be ineligible for all available exon 20 targeted therapies with proven benefit\n     * Cohort IIB: HER2 exon 20 insertion mutation, patients must have received platinum-based chemotherapy or other chemotherapy regimen if platinum- based chemotherapy was contraindicated. Additionally, patients must be naïve to a HER2 exon 20 targeted TKI\n     * Cohort IIC: Atypical EGFR mutation, patients may have received a prior EGFR TKI\n* Agreement and ability to undergo pretreatment biopsy\n* Measurable disease according to RECIST 1.1\n* CNS involvement, which is either previously treated and controlled, or untreated and asymptomatic\n* ECOG performance status of 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known EGFR T790M mutation\n* Leptomeningeal disease and spinal cord compression\n\n  \\-- Except if LMD has been reported radiographically on baseline MRI, but is not suspected clinically by the Investigator; the subject must be free of neurological symptoms of LMD\n* History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months\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* Known, symptomatic human immunodeficiency virus (HIV) infection\n* Known active infection requiring treatment or history of hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients positive for HBsAg but normal HBV DNA level are allowed.\n* Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes\n* Any other concurrent serious uncontrolled medical, psychological, or addictive conditions",{"count":86,"type":20},350,[23,88],"PHASE2","The purpose of this study is to establish the recommended Phase 2 dose (RP2D) and\u002For maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of ORIC-114 as a Single Agent or in Combination with Chemotherapy when administered to patients with advanced solid tumors harboring an EGFR or HER2 alteration.",[26],[92,93,94,95,28,96],"EGFR exon 20 insertion mutation","Atypical EGFR mutation","HER2 exon 20 insertion mutation","HER2 amplification\u002Foverexpression","Breast cancer","2025-07-31",{"date":99,"type":40},"2025-08-05",{"date":101,"type":40},"2022-03-10",{"date":103,"type":20},"2027-09",{"name":46,"class":47},42,""]