[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576353":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":35,"studyPopulation":11,"armGroups":36,"interventions":62,"overallOfficials":11,"centralContacts":76,"locations":84,"responsibleParty":171,"collaborators":11,"id":173,"slug":11,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":11,"eligibilityCriteria":178,"healthyVolunteers":174,"sex":179,"minAge":180,"maxAge":11,"enrollmentInfo":181,"targetDuration":11,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":193,"overallStatus":87,"whyStopped":11,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"Olema Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of participants with dose-limiting toxicities in the Dose Escalation Arms",null,"Up to 28 days",{"measure":14,"description":11,"timeFrame":15},"Incidence of adverse events and laboratory abnormalities","Up to 26 months",[17,19,21,23,25,27],{"measure":18,"description":11,"timeFrame":15},"Maximum observed concentration (Cmax)",{"measure":20,"description":11,"timeFrame":15},"Time to maximum concentration (Tmax)",{"measure":22,"description":11,"timeFrame":15},"Area under the curve from time zero to 24 hours (AUC0-24)",{"measure":24,"description":11,"timeFrame":15},"Overall Response Rate (ORR)",{"measure":26,"description":11,"timeFrame":15},"Duration of Response (DOR)",{"measure":28,"description":11,"timeFrame":15},"Clinical Benefit Rate (CBR)",{"allocation":30,"interventionModel":31,"interventionModelDescription":11,"primaryPurpose":32,"observationalModel":11,"timePerspective":11,"maskingInfo":33},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":34,"maskingDescription":11,"whoMasked":11},"NONE","Part 1A (Dose Escalation for OP-3136 Monotherapy): This part of the study will evaluate the safety, tolerability, and PK in a range of doses of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A\u002FB) inhibitor, administered orally once daily to participants with ER+ HER2- advanced or metastatic breast cancer (mBC), advanced or metastatic castration resistant prostate cancer (mCRPC), or advanced or metastatic non-small cell lung cancer (mNSCLC), and determine the maximum tolerated dose (MTD) and the recommended dose\u002Fregimen for expansion (RDE).\n\nPart 1B (Dose Escalation for OP-3136 in Combination with Fulvestrant): This part of the study will evaluate the safety and PK of OP-3136 administered in combination with fulvestrant in participants with ER+ HER2- mBC, and determine MTD and RDE for this combination.\n\nPart 1C (Dose Escalation for OP-3136 in Combination with Palazestrant): This part of the study will evaluate the safety and PK of OP-3136 administered in combination with palazestrant in participants with ER+ HER2- mBC, and determine MTD and RDE for this combination.\n\nPart 2A (Dose Expansion for OP-3136 Monotherapy): This part will evaluate two expansion cohorts at the monotherapy RDE from part 1 in participants with ER+ HER2- mBC and participants with mCRPC.\n\nPart 2B (Dose Expansion for OP-3136 in Combination with Fulvestrant OR Palazestrant): This part will evaluate the RDEs for OP-3136 in combination with fulvestrant from Part 1B OR the RDEs of OP-3136 in combination with palazestrant in an expansion cohort in participants with ER+ HER2- mBC.",[37,42,46,50,53,56,59],{"label":38,"type":39,"description":11,"interventionNames":40},"Part 1A Dose Escalation monotherapy","EXPERIMENTAL",[41],"Drug: OP-3136",{"label":43,"type":39,"description":11,"interventionNames":44},"Part 1B Dose Escalation in combination with fulvestrant",[41,45],"Drug: Fulvestrant",{"label":47,"type":39,"description":11,"interventionNames":48},"Part 1C Dose Escalation in combination with palazestrant",[41,49],"Drug: Palazestrant",{"label":51,"type":39,"description":11,"interventionNames":52},"Part 2A Dose Expansion monotherapy - mBC",[41],{"label":54,"type":39,"description":11,"interventionNames":55},"Part 2A Dose Expansion monotherapy - mCRPC",[41],{"label":57,"type":39,"description":11,"interventionNames":58},"Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1",[41,45,49],{"label":60,"type":39,"description":11,"interventionNames":61},"Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2",[41,45,49],[63,68,72],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":11},"DRUG","OP-3136","Selective inhibitor of HAT enzymes KAT6A and KAT6B",[38,43,47,51,54,57,60],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":11},"Fulvestrant","Selective estrogen receptor degrader (SERD)",[43,57,60],{"type":64,"name":73,"description":74,"armGroupLabels":75,"otherNames":11},"Palazestrant","Complete estrogen receptor antagonist (CERAN)",[47,57,60],[77,82],{"name":78,"role":79,"phone":80,"phoneExt":11,"email":81},"There may be multiple sites in this clinical trial Olema Clinical Trial Lead","CONTACT","415-651-7206","clinical@olema.com",{"name":83,"role":79,"phone":11,"phoneExt":11,"email":11},"Olema Medical Study Director",[85,99,109,119,129,139,149,159],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":11},"Florida Cancer Specialists","RECRUITING","Sarasota","Florida","34232","United States","US",{"type":94,"coordinates":95},"Point",[96,97],-82.53065,27.33643,{"lat":97,"lon":96},{"facility":100,"status":87,"city":101,"state":102,"zip":103,"country":91,"countryCode":92,"cosmosGeoPoint":104,"geoPoint":108,"contacts":11},"University Medical Center - New Orleans","New Orleans","Louisiana","70112",{"type":94,"coordinates":105},[106,107],-90.07507,29.95465,{"lat":107,"lon":106},{"facility":110,"status":87,"city":111,"state":112,"zip":113,"country":91,"countryCode":92,"cosmosGeoPoint":114,"geoPoint":118,"contacts":11},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",{"type":94,"coordinates":115},[116,117],-71.05977,42.35843,{"lat":117,"lon":116},{"facility":120,"status":87,"city":121,"state":122,"zip":123,"country":91,"countryCode":92,"cosmosGeoPoint":124,"geoPoint":128,"contacts":11},"START - Midwest","Grand Rapids","Michigan","49546",{"type":94,"coordinates":125},[126,127],-85.66809,42.96336,{"lat":127,"lon":126},{"facility":130,"status":87,"city":131,"state":132,"zip":133,"country":91,"countryCode":92,"cosmosGeoPoint":134,"geoPoint":138,"contacts":11},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":94,"coordinates":135},[136,137],-86.78444,36.16589,{"lat":137,"lon":136},{"facility":140,"status":87,"city":141,"state":142,"zip":143,"country":91,"countryCode":92,"cosmosGeoPoint":144,"geoPoint":148,"contacts":11},"START - San Antonio","San Antonio","Texas","78229",{"type":94,"coordinates":145},[146,147],-98.49363,29.42412,{"lat":147,"lon":146},{"facility":150,"status":87,"city":151,"state":152,"zip":153,"country":91,"countryCode":92,"cosmosGeoPoint":154,"geoPoint":158,"contacts":11},"START - Mountain Region","West Valley City","Utah","84119",{"type":94,"coordinates":155},[156,157],-112.00105,40.69161,{"lat":157,"lon":156},{"facility":160,"status":87,"city":161,"state":162,"zip":163,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":11},"Cancer Research South Australia","Adelaide","South Australia","5000","Australia","AU",{"type":94,"coordinates":167},[168,169],138.59863,-34.92866,{"lat":169,"lon":168},{"type":172,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":182,"type":183},180,"ESTIMATED","INTERVENTIONAL",[186],"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).",[189,190,191,192,69,73],"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",[194,195,196],"KAT6 Inhibitor","Histone Acetyltransferase (HAT) Inhibitor","Epigenetic","2025-10-08",{"date":199,"type":200},"2025-10-10","ACTUAL",{"date":202,"type":200},"2024-12-16",{"date":204,"type":183},"2027-08-30",{"name":5,"class":6},8]