[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Olema Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,59,82,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100599536","phase-3-palazestrant-in-combination-with-ribociclib-for-the-first-line-treatment-of-erher2--advanced-breast-cancer-100599536",false,"NCT07085767","Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+\u002FHER2- Advanced Breast Cancer","A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)","OPERA-02","Inclusion Criteria:\n\n* Adult female or male participants.\n* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.\n* Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).\n* De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4\u002F6 inhibitors)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal functions.\n* Female participants can be pre-, peri- or postmenopausal.\n* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.\n\nExclusion Criteria:\n\n* Disease recurrence during adjuvant endocrine therapy\n* Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.\n* Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.\n* History of allergic reactions to study treatment.\n* Any contraindications to letrozole and ribociclib.\n* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.","ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.",[27,28,29,30,31],"Breast Cancer","Locally Advanced Breast Cancer","Metastatic Breast Cancer","ER Positive Breast Cancer","HER2 Negative Breast Carcinoma",[33,34,35,36,37,38,39,40,41,42,43,44,45],"Randomized","Multicenter","Double-Blind","Active-Controlled","Phase 3","Palazestrant","Complete Estrogen Receptor Antagonist (CERAN)","Selective Estrogen Receptor Degrader (SERD)","Ribociclib","CDK4\u002F6i","Letrozole","Aromatase inhibitors","Antineoplastic agents","RECRUITING","2026-06-12",{"date":49,"type":50},"2026-06-16","ACTUAL",{"date":52,"type":50},"2025-11-03",{"date":54,"type":21},"2032-01",{"name":56,"class":57},"Olema Pharmaceuticals, Inc.","INDUSTRY",150,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100517376","phase-3-op-1250-palazestrant-vs-standard-of-care-for-the-treatment-of-erher2--advanced-breast-cancer-100517376","NCT06016738","OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+\u002FHER2- Advanced Breast Cancer","A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4\u002F6 Inhibitor Therapy (OPERA-01)","OPERA-01","Key inclusion criteria:\n\n* Adult female or male participants.\n* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.\n* Evaluable disease (measurable disease or bone-only disease).\n* Previously received a CDK4\u002F6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal functions.\n* Female participants can be pre-, peri- or postmenopausal.\n* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.\n\nKey exclusion criteria:\n\n* Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.\n* Previously received chemotherapy in the advanced\u002Fmetastatic setting.\n* Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.\n* History of allergic reactions to study treatment.\n* Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.\n* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.\n* Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.",{"count":68,"type":21},510,[24],"This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4\u002F6 inhibitor.",[27,72,29,30,31],"Advanced Breast Cancer","2026-03-11",{"date":75,"type":50},"2026-03-13",{"date":77,"type":50},"2023-11-16",{"date":79,"type":21},"2027-09-30",{"name":56,"class":57},233,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100478356","phase-1-phase-1b-study-of-op-1250-palazestrant-in-combination-with-ribociclib-alpelisib-everolimus-or-atirmociclib-in-er-her2--breast-cancer-100478356","NCT05508906","Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer","A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4\u002F6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and\u002For Metastatic ER Positive, HER2 Negative Breast Cancer","Inclusion Criteria:\n\n* Female or male aged \\>18 years.\n* Willing and able to participate and comply with all study requirements.\n* Histologically- or cytologically-confirmed advanced or metastatic Breast Cancer (mBC).\n* ER+\u002FHER2- disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report.\n* Evaluable disease with one of the following: Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR patients with predominantly bone disease (with or without other non-measurable lesions) are allowed if it is possible to evaluate on radiological examinations (eg. bone scan, PET\u002FCT, CT, MRI) even if lesions are non-measurable according to RECIST 1.1.\n* Life expectancy ≥6 months, as judged by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Has received no more than 1 prior hormonal regimen (Treatment Group 1). Has received no more than 2 prior hormonal regimens (Treatment Group 2 and Treatment Group 3) . Has received no more than 2 prior hormonal regimens for metastatic disease in Part 1 (Dose Escalation) and no more than 1 prior hormonal regimes in Part 2 (Dose Expansion) for metastatic disease, regardless of type of endocrine agent (Treatment Group 4) for advanced or metastatic disease. Prior hormonal regimens in combination with CDK4\u002F6 inhibitors are allowed in all treatment groups. For subjects in Treatment Group 4, no prior chemotherapy for metastatic breast cancer is allowed.\n* Has received no more than 1 prior chemotherapy (which includes antibody drug conjugates) for locally advanced or metastatic breast cancer.\n\nExclusion Criteria:\n\n* Prior or concurrent malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* History of cerebral vascular disease within 6 months prior to the first administration of study drug dose.\n* History of a pulmonary embolism, or deep venous thrombosis within the last 6 months, or subject has an increased risk of thrombosis as determined by the investigator.\n* History of pneumonitis or interstitial lung disease.\n* Leptomeningeal disease or spinal cord compression.\n* Medical history or ongoing gastrointestinal disorders that could affect absorption of oral therapeutics.\n* Known human immunodeficiency virus infection.\n* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (eg, hepatitis B or hepatitis C virus), current alcohol abuse, or cirrhosis.\n* History of severe cutaneous reaction, such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms.\n* Active infection or at a high risk of developing a serious infection (e.g. participants with immunodeficiencies, uncontrolled diabetes mellitus, uncontrolled heart disease, poor general health, poor nutritional status).\n* Has clinically significant co-morbidities, such as, psychiatric disease, or any other condition that could impact the ability of the subject to participate in this study or otherwise has the potential to confound the study results.\n* Have received prior treatment with OP-1250.\n* Have received prior treatment with approved or investigational PI3K inhibitor (Treatment Group 2) or mTOR inhibitor (Treatment Group 3).",{"count":90,"type":21},190,[92],"PHASE1","This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows:\n\nTreatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).\n\nTreatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation).\n\nTreatment Group 3: Palazestrant (OP-1250) in combination with everolimus.\n\nTreatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.",[29,95,96,27,28],"ER-positive Breast Cancer","HER2-negative Breast Cancer","2025-10-20",{"date":99,"type":50},"2025-10-22",{"date":101,"type":50},"2022-08-31",{"date":103,"type":21},"2028-01-31",{"name":56,"class":57},16,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100576353","phase-1-phase-1-study-of-op-3136-in-advanced-or-metastatic-solid-tumors-100576353","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.",{"count":114,"type":21},180,[92],"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).",[118,119,120,29,121,38],"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)","Fulvestrant",[123,124,125],"KAT6 Inhibitor","Histone Acetyltransferase (HAT) Inhibitor","Epigenetic","2025-10-08",{"date":128,"type":50},"2025-10-10",{"date":130,"type":50},"2024-12-16",{"date":132,"type":21},"2027-08-30",{"name":56,"class":57},8,""]