[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576353":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":11,"centralContacts":48,"locations":56,"responsibleParty":143,"collaborators":11,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":11,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":11,"enrollmentInfo":154,"targetDuration":11,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":166,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Olema Pharmaceuticals, Inc.","INDUSTRY",[8,14,18,22,25,28,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1A Dose Escalation monotherapy","EXPERIMENTAL",null,[13],"Drug: OP-3136",{"label":15,"type":10,"description":11,"interventionNames":16},"Part 1B Dose Escalation in combination with fulvestrant",[13,17],"Drug: Fulvestrant",{"label":19,"type":10,"description":11,"interventionNames":20},"Part 1C Dose Escalation in combination with palazestrant",[13,21],"Drug: Palazestrant",{"label":23,"type":10,"description":11,"interventionNames":24},"Part 2A Dose Expansion monotherapy - mBC",[13],{"label":26,"type":10,"description":11,"interventionNames":27},"Part 2A Dose Expansion monotherapy - mCRPC",[13],{"label":29,"type":10,"description":11,"interventionNames":30},"Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1",[13,17,21],{"label":32,"type":10,"description":11,"interventionNames":33},"Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2",[13,17,21],[35,40,44],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"DRUG","OP-3136","Selective inhibitor of HAT enzymes KAT6A and KAT6B",[9,15,19,23,26,29,32],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"Fulvestrant","Selective estrogen receptor degrader (SERD)",[15,29,32],{"type":36,"name":45,"description":46,"armGroupLabels":47,"otherNames":11},"Palazestrant","Complete estrogen receptor antagonist (CERAN)",[19,29,32],[49,54],{"name":50,"role":51,"phone":52,"phoneExt":11,"email":53},"There may be multiple sites in this clinical trial Olema Clinical Trial Lead","CONTACT","415-651-7206","clinical@olema.com",{"name":55,"role":51,"phone":11,"phoneExt":11,"email":11},"Olema Medical Study Director",[57,71,81,91,101,111,121,131],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":11},"Florida Cancer Specialists","RECRUITING","Sarasota","Florida","34232","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-82.53065,27.33643,{"lat":69,"lon":68},{"facility":72,"status":59,"city":73,"state":74,"zip":75,"country":63,"countryCode":64,"cosmosGeoPoint":76,"geoPoint":80,"contacts":11},"University Medical Center - New Orleans","New Orleans","Louisiana","70112",{"type":66,"coordinates":77},[78,79],-90.07507,29.95465,{"lat":79,"lon":78},{"facility":82,"status":59,"city":83,"state":84,"zip":85,"country":63,"countryCode":64,"cosmosGeoPoint":86,"geoPoint":90,"contacts":11},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",{"type":66,"coordinates":87},[88,89],-71.05977,42.35843,{"lat":89,"lon":88},{"facility":92,"status":59,"city":93,"state":94,"zip":95,"country":63,"countryCode":64,"cosmosGeoPoint":96,"geoPoint":100,"contacts":11},"START - Midwest","Grand Rapids","Michigan","49546",{"type":66,"coordinates":97},[98,99],-85.66809,42.96336,{"lat":99,"lon":98},{"facility":102,"status":59,"city":103,"state":104,"zip":105,"country":63,"countryCode":64,"cosmosGeoPoint":106,"geoPoint":110,"contacts":11},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":66,"coordinates":107},[108,109],-86.78444,36.16589,{"lat":109,"lon":108},{"facility":112,"status":59,"city":113,"state":114,"zip":115,"country":63,"countryCode":64,"cosmosGeoPoint":116,"geoPoint":120,"contacts":11},"START - San Antonio","San Antonio","Texas","78229",{"type":66,"coordinates":117},[118,119],-98.49363,29.42412,{"lat":119,"lon":118},{"facility":122,"status":59,"city":123,"state":124,"zip":125,"country":63,"countryCode":64,"cosmosGeoPoint":126,"geoPoint":130,"contacts":11},"START - Mountain Region","West Valley City","Utah","84119",{"type":66,"coordinates":127},[128,129],-112.00105,40.69161,{"lat":129,"lon":128},{"facility":132,"status":59,"city":133,"state":134,"zip":135,"country":136,"countryCode":137,"cosmosGeoPoint":138,"geoPoint":142,"contacts":11},"Cancer Research South Australia","Adelaide","South Australia","5000","Australia","AU",{"type":66,"coordinates":139},[140,141],138.59863,-34.92866,{"lat":141,"lon":140},{"type":144,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":155,"type":156},180,"ESTIMATED","INTERVENTIONAL",[159],"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).",[162,163,164,165,41,45],"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",[167,168,169],"KAT6 Inhibitor","Histone Acetyltransferase (HAT) Inhibitor","Epigenetic","2025-10-08",{"date":172,"type":173},"2025-10-10","ACTUAL",{"date":175,"type":173},"2024-12-16",{"date":177,"type":156},"2027-08-30",{"name":5,"class":6},8]