[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04115306":3,"trial-entities:NCT04115306":182,"trial-summary:NCT04115306":188},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":36,"interventions":39,"primary_outcomes":52,"secondary_outcomes":57,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":15,"eligibility_criteria":69,"std_ages":95,"locations":98,"central_contacts":178,"overall_officials":179,"references":180,"see_also_links":181},"NCT04115306","PMD-026-1-001","Phase 1\u002F1b\u002F2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer","Ph 1\u002F1b\u002F2 Multicenter, Open-Label, FIH Dose Esc & Dose Exp Study to Assess Safety and Tolerability of Orally Administered PMD-026 as a Single Agent and in Combination in Patients With Metastatic or Locally Advanced (Inoperable) RSK2+ Breast Cancer","ACTIVE_NOT_RECRUITING","2026-12","2026-04","2026-07-16","2019-11-14","Phoenix Molecular Designs","INDUSTRY",false,"The purpose of this study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer.","Combination with fulvestrant (Part 3):\n\nThis study will enroll RSK2+, HR+, and human epidermal growth factor receptor 2 negative (HER2-) patients to evaluate PMD-026 in combination with a standard dose and schedule of fulvestrant. Fulvestrant will be dosed per the package insert in combination with PMD-026 at the RP2D determined in the monotherapy phase of the study. Up to 20 patients will be enrolled with locally advanced or metastatic HR+\u002FHER2- breast cancer previously treated with a CDK4\u002F6 inhibitor in combination with endocrine therapy.",[19],"Metastatic Breast Cancer",[21,22,23,24,25,26,27,28,29,30],"invasive breast cancer","PR-negative breast cancer","HER2-negative breast cancer","Breast cancer","Breast malignancy","breast malignancies","metastatic breast cancer","advanced breast cancer","solid tumor","late stage breast cancer\u002Flate-stage breast cancer","INTERVENTIONAL","TREATMENT",[34,35],"PHASE1","PHASE2",{"count":37,"type":38},61,"ESTIMATED",[40,46],{"type":41,"name":42,"description":43,"armGroupLabels":44},"DRUG","PMD-026","Investigational Drug",[45],"Oral PMD-026 in combination with fulvestrant",{"type":41,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"fulvestrant","SERDs",[45],[51],"Faslodex",[53],{"measure":54,"description":55,"timeFrame":56},"Safety and tolerability of PMD-026 in combination with fulvestrant in patients with HR+\u002FHER2- previously treated breast cancer","Incidence of AEs, DLTs, SAEs. Changes in laboratory, vital signs, and ECG values.","6 weeks",[58,62],{"measure":59,"description":60,"timeFrame":61},"Plasma concentration of PMD-026 when administered in combination with fulvestrant","The plasma concentration will be measured as part of pharmacokinetic (PK) testing.","As determined by PK data",{"measure":63,"description":64,"timeFrame":65},"Preliminary anti-tumor activity of PMD-026 when dosed in combination with fulvestrant","ORR, DOR, DCR, PFS","Until PD or death, up to 2 years","ALL","18 Years",null,{"inclusion":70,"exclusion":82,"raw_text":94},[71,72,73,74,75,76,77,78,79,80,81],"RSK2 positive from available archival or fresh tumor tissue (FFPE).","Histologically or cytologically diagnosed HR+, HER2-","ESR1 wild type","Diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amendable to resection or radiation with curative intent or metastatic disease not amendable to curative therapy","Must be appropriate candidates for endocrine therapy","Previously received at least 1 line of endocrine therapy for MBC or had recurrence while on adjuvant endocrine therapy for locally advanced breast cancer","Discontinued endocrine therapy at least 15 days prior to first dose of PMD-026","At least 1 measurable target lesion as defined by RECIST v1.1","Progression on or after treatment with a CDK4\u002F6 inhibitor in combination with endocrine therapy inhibitor in the locally advanced or metastatic setting","Adequate hematologic, hepatic, and renal function as assessed by laboratory parameters","Toxicity related to prior therapy resolved to at least Grade 1 (alopecia excepted) or to at least Grade 2 with prior approval of the Medical Monitor",[83,84,85,86,87,88,89,90,91,92,93],"Prior chemotherapy","ESR1 mutations","≤14 days from biological or investigational therapy","Presence of visceral crisis or uncontrolled visceral disease for which chemotherapy would be indicated","Central nervous system metastases, unless appropriately treated and neurologically stable","History of leptomeningeal metastases","Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy","Known hepatitis B or hepatitis C infection","Known HIV-positive with CD4+ cell counts \\\u003C350 cells\u002FμL","Known HIV-positive with a history of an AIDS-defining opportunistic infection","History of clinically significant cardiovascular abnormalities, including QTcF interval \\>460 msec (using Fridericia's formula)","Inclusion Criteria, Combination with fulvestrant (Part 3):\n\n* RSK2 positive from available archival or fresh tumor tissue (FFPE).\n* Histologically or cytologically diagnosed HR+, HER2-\n* ESR1 wild type\n* Diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amendable to resection or radiation with curative intent or metastatic disease not amendable to curative therapy\n* Must be appropriate candidates for endocrine therapy\n* Previously received at least 1 line of endocrine therapy for MBC or had recurrence while on adjuvant endocrine therapy for locally advanced breast cancer\n* Discontinued endocrine therapy at least 15 days prior to first dose of PMD-026\n* At least 1 measurable target lesion as defined by RECIST v1.1\n* Progression on or after treatment with a CDK4\u002F6 inhibitor in combination with endocrine therapy inhibitor in the locally advanced or metastatic setting\n* Adequate hematologic, hepatic, and renal function as assessed by laboratory parameters\n* Toxicity related to prior therapy resolved to at least Grade 1 (alopecia excepted) or to at least Grade 2 with prior approval of the Medical Monitor\n\nExclusion Criteria, Combination with fulvestrant (Part 3):\n\n* Prior chemotherapy\n* ESR1 mutations\n* ≤14 days from biological or investigational therapy\n* Presence of visceral crisis or uncontrolled visceral disease for which chemotherapy would be indicated\n* Central nervous system metastases, unless appropriately treated and neurologically stable\n* History of leptomeningeal metastases\n* Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy\n* Known hepatitis B or hepatitis C infection\n* Known HIV-positive with CD4+ cell counts \\\u003C350 cells\u002FμL\n* Known HIV-positive with a history of an AIDS-defining opportunistic infection\n* History of clinically significant cardiovascular abnormalities, including QTcF interval \\>460 msec (using Fridericia's formula)",[96,97],"ADULT","OLDER_ADULT",[99,108,116,123,130,138,146,154,162,170],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"Banner MD Anderson Cancer Center","Gilbert","Arizona","85234","United States",{"lat":106,"lon":107},33.35283,-111.78903,{"facility":109,"city":110,"state":111,"zip":112,"country":104,"geoPoint":113},"City of Hope","Duarte","California","91010",{"lat":114,"lon":115},34.13945,-117.97729,{"facility":117,"city":118,"state":111,"zip":119,"country":104,"geoPoint":120},"City of Hope Orange County, Lennar","Irvine","92618",{"lat":121,"lon":122},33.66946,-117.82311,{"facility":124,"city":125,"state":111,"zip":126,"country":104,"geoPoint":127},"University of California, Los Angeles (UCLA)","Los Angeles","90095",{"lat":128,"lon":129},34.05223,-118.24368,{"facility":131,"city":132,"state":133,"zip":134,"country":104,"geoPoint":135},"Moffitt Cancer Center","Tampa","Florida","33612",{"lat":136,"lon":137},27.94752,-82.45843,{"facility":139,"city":140,"state":141,"zip":142,"country":104,"geoPoint":143},"City of Hope Chicago","Zion","Illinois","60099",{"lat":144,"lon":145},42.44613,-87.83285,{"facility":147,"city":148,"state":149,"zip":150,"country":104,"geoPoint":151},"Massachusetts General Hospital Cancer Center","Boston","Massachusetts","02114",{"lat":152,"lon":153},42.35843,-71.05977,{"facility":155,"city":156,"state":157,"zip":158,"country":104,"geoPoint":159},"Profound Research","Farmington Hills","Michigan","48334",{"lat":160,"lon":161},42.48531,-83.37716,{"facility":163,"city":164,"state":165,"zip":166,"country":104,"geoPoint":167},"Ohio State University","Columbus","Ohio","43210",{"lat":168,"lon":169},39.96118,-82.99879,{"facility":171,"city":172,"state":173,"zip":174,"country":104,"geoPoint":175},"South Texas Accelerated Research Therapeutics","San Antonio","Texas","78229",{"lat":176,"lon":177},29.42412,-98.49363,[],[],[],[],{"nct_id":4,"conditions":183,"biomarkers":185},[184],"Breast Carcinoma",[186,187],"HR LYSINE DEMETHYLASE AND NUCLEAR RECEPTOR COREPRESSOR","RPS6KA3 wt Allele",{"nct_id":4,"found":15,"summary":68,"prompt_version":68}]