[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Halda Therapeutics OpCo, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"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":25,"conditions":26,"keywords":28,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100577593","phase-1-study-of-hld-0915-in-patients-with-metastatic-prostate-cancer-100577593",false,"NCT06800313","Study of HLD-0915 in Patients With Metastatic Prostate Cancer","Phase 1\u002F2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer","Patients must meet the following criteria to be eligible study participation:\n\nKey Inclusion Criteria:\n\nAll Study Arms (Phase 1 Part 1 \\& 2, Phase 2 Part 1, Part 2A, 2B, 2C \\& 2D):\n\nMales ≥ 18 years old Histological, pathological, and\u002For cytological confirmation of prostate adenocarcinoma Adequate hematological, renal, and hepatic function. Able to swallow oral medication\n\nmCRPC Arms: (Phase 1 Part 1 \\& 2, Phase 2 Part 1): Prior orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone Progressive mCRPC defined as having demonstrated PSA progression on the prior regimen\n\nSOAR Arm (Phase 2 Part 2A) mHSPC with distant metastatic disease based on conventional imaging PSA ≥0.2 ng\u002FmL, following treatment with next generation ARPI for at least 180 days and up to 365 days No evidence of radiographic or PSA progression while receiving ARPI\n\nmHSPC arms (Phase 2 Part 2B, 2C \\& 2D) serum testosterone \\>150ng\u002Fml mHSPC with distant metastatic disease based on conventional imaging and PSA \\>2.0 ng\u002FmL\n\nKey Exclusion Criteria:\n\nAll arms (Phase 1 Part 1 \\& 2, Phase 2 Part 1, Part 2A, 2B, 2C \\& 2D):\n\nHas experienced a recent major bleed or has a known bleeding disorder Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology Receiving continuous corticosteroids at prednisone-equivalent dose of \\>10 mg\u002Fday Prior or ongoing significant medical condition\n\nmCRPC arms: (Phase 1 Part 1 \\& 2, Phase 2 Part 1): Has received systemic anti-cancer therapy or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods\n\nSOAR arm (Phase 2 Part 2A) Has received any prior cytotoxic chemotherapy for prostate cancer\n\nmHSPC arms (Phase 2 Part 2B, 2C \\& 2D) regional pelvic lymph node disease only","MALE","18 Years",{"count":19,"type":20},190,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Assessment of the safety and efficacy of HLD-0915 in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.",[27],"Metastatic Prostate Cancer",[29,30,31,32,33,34,35,36,37,38,39,40],"Prostate Cancer","RIPTAC","HLD-0915","Genital Neoplasms, Male","Urogenital Neoplasms, Male","Genital Diseases, Male","Urogenital Diseases, Male","Neoplasms, Glandular and Epithelial","Prostatic Neoplasms","Prostate Adenocarcinoma","Hormone Sensitive, Castrate Resistant","Metastatic Castrate Resistant Prostate Cancer","RECRUITING","2026-06-24",{"date":44,"type":45},"2026-06-26","ACTUAL",{"date":47,"type":45},"2025-02-20",{"date":49,"type":20},"2030-04",{"name":51,"class":52},"Halda Therapeutics OpCo, Inc.","INDUSTRY",12,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":62,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100633297","phase-1-a-study-of-hld-0117-in-patients-with-metastatic-breast-cancer-100633297","NCT07524855","A Study of HLD-0117 in Patients With Metastatic Breast Cancer","A Phase 1 Study of HLD-0117 in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC)","HLD-0117","Inclusion Criteria:\n\n* Female (assigned at birth), ≥18 years old, and able to provide informed consent\n* Histologically confirmed metastatic or locally advanced breast cancer\n* Postmenopausal status defined by surgical or natural menopause, or ovarian suppression with a GnRH agonist\n* Prior treatment including at least one endocrine therapy in the metastatic setting, at least one CDK4\u002F6 inhibitor (in the adjuvant and\u002For metastatic setting), and no more than two prior cytotoxic regimens in the metastatic setting\n* Radiologic disease progression on the most recent therapy\n* Measurable disease per RECIST v1.1\n* Willingness to provide baseline and on-treatment tumor biopsies, unless not feasible or medically appropriate\n* ER-positive and HER2-negative status documented within 2 years\n* ECOG performance status 0-1 and life expectancy of at least 3 months\n* Adequate organ function Recovery from prior therapy-related toxicities to Grade ≤1 (except alopecia; neuropathy and endocrinopathies ≤Grade 2)\n* Ability to swallow oral medication and comply with study procedures\n* Stable dose (≥30 days) of bisphosphonates or denosumab, if applicable\n\nExclusion Criteria:\n\n* Inflammatory breast cancer or known brain metastases\n* Recent major bleeding or uncontrolled bleeding disorder\n* Ongoing corticosteroid use \\>10 mg\u002Fday (prednisone equivalent)\n* Recent anticancer or investigational therapy within 14 days (28 days for fulvestrant)\n* Untreated or unstable spinal cord compression\n* Significant cardiovascular disease within 6 months or ongoing uncontrolled cardiac conditions\n* Active or uncontrolled infection (controlled HIV or treated hepatitis C allowed)\n* Uncontrolled renal, pancreatic, or liver disease (excluding stable conditions such as Gilbert's syndrome or liver metastases)\n* Another malignancy requiring treatment within 2 years (except low-risk, curatively treated cancers)\n* Major surgery within 28 days\n* Any condition that may interfere with safety or study compliance\n* Pregnancy or breastfeeding","FEMALE",{"count":64,"type":20},33,[23],"Assessment of the safety and efficacy of HLD-0117 as monotherapy in patients with estrogen receptor positive (ER+) metastatic breast cancer (MBC) or locally advanced breast cancer that have progressed on prior systemic therapies.",[68],"Metastatic Breast Cancer",[70,30,71,72,73,74],"breast cancer","breast carcinoma","locally advanced breast cancer","breast tumor","malignant Tumor of the breast","2026-05-29",{"date":77,"type":45},"2026-06-02",{"date":79,"type":45},"2026-04-09",{"date":81,"type":20},"2028-04-30",{"name":51,"class":52},4,""]