[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-or-metastatic-non-small-cell-lung-cancer-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-or-metastatic-non-small-cell-lung-cancer-nsclc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100576353","phase-1-phase-1-study-of-op-3136-in-advanced-or-metastatic-solid-tumors-100576353",false,"NCT06784193","Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors","A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Participants with advanced or metastatic ER+HER2- breast cancer, mCRPC, or NSCLC (Part 1) or advanced or metastatic ER+HER2- BC or mCRPC (Part 2).\n* Part 1A (Dose escalation for OP-3136 monotherapy): Participants must have a tumor that is unresectable or metastatic and for which life prolonging measures do not exist or available therapies are intolerable or no longer effective.\n* Part 1B (Dose escalation for OP-3136 in combination with fulvestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4\u002F6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4\u002F6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.\n* Part 1C (Dose escalation for OP-3136 in combination with palazestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4\u002F6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4\u002F6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.\n* Part 2A (Dose Expansion in ER+ HER2- mBC for OP-3136 monotherapy): Participants must have received up to 3 prior lines of endocrine therapy (one of which must be in combination with CDK4\u002F6 inhibitor) and up to 1 prior line of chemotherapy or an antibody-drug conjugate.\n* Part 2A (Dose Expansion in mCRPC for OP-3136 monotherapy): Participants must have received up to 4 lines of prior systemic therapy for prostate cancer. Prior therapy must include treatment with an androgen receptor pathway inhibitor(s).\n* Part 2B (Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with fulvestrant OR Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with palazestrant): Participants must have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4\u002F6 inhibitor in advanced or metastatic setting. Participants must have received no more than 2 prior lines of endocrine therapy in the advanced or metastatic setting and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.\n\nKey Exclusion Criteria:\n\n* Prior therapy with KAT6A\u002FB inhibitor in any treatment setting.\n* Participants with advanced\u002Fmetastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term.\n* Known active or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require CNS-specific treatment, or participants who did not demonstrate clinical and radiologic stability during the last 2 months prior to the first dose of study treatment or require or are currently on steroid therapy for CNS metastases.\n* History of cerebral vascular disease, including transient ischemic attack, within 6 months prior to the first dose of study treatment.\n* History of or ongoing impaired cardiac function or clinically significant cardiac disease within 6 months prior to the first dose of study treatment.\n\nNote: Additional inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A\u002FB) inhibitor, as monotherapy and in combination with other anticancer agents in participants with advanced solid tumors.\n\nThis study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2).",[26,27,28,29,30,31],"Advanced or Metastatic ER+ HER2- Breast Cancer (mBC)","Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Metastatic Breast Cancer","Fulvestrant","Palazestrant",[33,34,35],"KAT6 Inhibitor","Histone Acetyltransferase (HAT) Inhibitor","Epigenetic","RECRUITING","2025-10-08",{"date":39,"type":40},"2025-10-10","ACTUAL",{"date":42,"type":40},"2024-12-16",{"date":44,"type":20},"2027-08-30",{"name":46,"class":47},"Olema Pharmaceuticals, Inc.","INDUSTRY",8]