[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07015697":3,"trial-entities:NCT07015697":256,"trial-summary:NCT07015697":262},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":51,"sex":62,"minimum_age":63,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":74,"locations":77,"central_contacts":247,"overall_officials":253,"references":254,"see_also_links":255},"NCT07015697","DS8201-801","A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors","A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors","RECRUITING","2028-12-31","2026-07","2026-07-09","2025-07-17","Daiichi Sankyo","INDUSTRY",false,"This dose escalation and dose expansion study was designed to assess the safety, tolerability, PK and efficacy of subcutaneous T-DXd in participants with metastatic solid tumors.",null,[19],"Recurrent or Metastatic Solid Tumors",[21,22,23],"T-DXd","solid tumor","subcutaneous","INTERVENTIONAL","TREATMENT",[27],"PHASE1",{"count":29,"type":30},76,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":39},"DRUG","Trastuzumab Deruxtecan","Dose Escalation Part: Trastuzumab Deruxtecan will be administered at escalating doses to determine the RDE.\n\nExpansion Part: Trastuzumab Deruxtecan will be administered at RDE.",[37,38],"Part 1 (Dose Escalation)","Part 2 (Dose Expansion)",[21,40],"ENHERTU®",[42,46,49],{"measure":43,"description":44,"timeFrame":45},"Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)","TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 21 days after the last dose date of trial intervention).","From the start of trial intervention to 21 days after the last dose, up to approximately 9 months",{"measure":47,"timeFrame":48},"Area Under Curve (AUC)","From the start of trial intervention to last dose, up to approximately 9 months",{"measure":50,"timeFrame":45},"Number of Participants with Dose limiting toxicities (DLT) During the Dose-Escalation Phase",[52,55,59],{"measure":53,"timeFrame":54},"Percentage of Participants with Anti-Drug Antibody (ADAs)","From baseline to post-baseline, up to approximately 12 months",{"measure":56,"description":57,"timeFrame":58},"Overall Response Rate (ORR)","ORR is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by investigator per RECIST v1.1","From the enrollment\u002Frandomization date until documented disease progression, up to 12 months",{"measure":60,"description":61,"timeFrame":58},"Disease Control Rate (DCR)","DCR is defined as the proportion of participants with a BOR of confirmed CR, confirmed PR, or stable disease (SD) per RECIST v1.1.","ALL","18 Years",{"inclusion":65,"exclusion":72,"raw_text":73},[66,67,68,69,70,71],"the metastatic setting, or","the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy. HR-, HER2-low BC: have received a prior systemic cytotoxic therapy in the metastatic setting; or developed disease recurrence during or within 6 months of completing (neo)adjuvant chemotherapy. HR+, HER2-low\u002Fultralow BC: have received previous ET AND an additional line of ET must not be the next line of treatment considered in the participant's best interest.","For participants in Part 2 with HR+ HER-2low\u002Fultralow BC, the following criteria also apply:","had disease progression while receiving 1 previous line of ET with a CDK4\u002F6i and is not expected to benefit from immediate use of a second line of ET, OR","had disease progression on at least 2 previous lines of ET with or without a target therapy such as CDK4\u002F6, mTOR or PI3-K inhibitors) administered for the treatment of metastatic disease","participants may not have received more than 2 prior lines of cytotoxic therapy in the recurrent or metastatic setting. NSCLC, HER2 mut: adults with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.",[],"Key Inclusion Criteria:\n\n1. Adults ≥18 years or the minimum legal adult age (whichever is greater).\n2. a) Disease State: If HER2 status is required for eligibility (for all populations), a documented HER2 test result must be available.\n\n   Breast Cancer: adults with pathologically documented unresectable or metastatic breast cancer HER2-positive BC: have received a prior anti-HER2-based regimen. For HER2-positive BC participants in Part 2 only, prior anti-HER2 based therapy should have been received in either:\n   * the metastatic setting, or\n   * the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy. HR-, HER2-low BC: have received a prior systemic cytotoxic therapy in the metastatic setting; or developed disease recurrence during or within 6 months of completing (neo)adjuvant chemotherapy. HR+, HER2-low\u002Fultralow BC: have received previous ET AND an additional line of ET must not be the next line of treatment considered in the participant's best interest.\n   * For participants in Part 2 with HR+ HER-2low\u002Fultralow BC, the following criteria also apply:\n   * had disease progression while receiving 1 previous line of ET with a CDK4\u002F6i and is not expected to benefit from immediate use of a second line of ET, OR\n   * had disease progression on at least 2 previous lines of ET with or without a target therapy such as CDK4\u002F6, mTOR or PI3-K inhibitors) administered for the treatment of metastatic disease\n   * participants may not have received more than 2 prior lines of cytotoxic therapy in the recurrent or metastatic setting. NSCLC, HER2 mut: adults with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.\n\n     b) Part 2 only: At least 1 RECIST 1.1 measurable lesion on CT or MRI.\n3. Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting trial intervention.\n\nKey Exclusion Criteria:\n\n1\\. Prior treatment with ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor; 4. Medical history of MI within 6 months before enrollment or symptomatic CHF (New York Heart Association class II to IV). Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any MI-related symptoms should have a cardiologic consultation during the Screening Period to rule out MI.\n\n5\\. Has a corrected QT interval (QTcF) prolongation to \\> 480 ms (regardless of participant's sex) based on average of the screening triplicate 12-lead ECG. 6. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.",[75,76],"ADULT","OLDER_ADULT",[78,87,94,101,108,115,122,130,136,142,148,154,158,163,169,175,181,184,187,193,199,202,205,207,213,218,223,229,234,240,242],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"Research Site","Newport Beach","California","92663","United States",{"lat":85,"lon":86},33.61891,-117.92895,{"facility":79,"status":8,"city":88,"state":89,"zip":90,"country":83,"geoPoint":91},"Atlanta","Georgia","30322",{"lat":92,"lon":93},33.749,-84.38798,{"facility":79,"status":8,"city":95,"state":96,"zip":97,"country":83,"geoPoint":98},"Las Vegas","Nevada","89169",{"lat":99,"lon":100},36.17497,-115.13722,{"facility":79,"status":8,"city":102,"state":103,"zip":104,"country":83,"geoPoint":105},"Charlotte","North Carolina","28204",{"lat":106,"lon":107},35.22709,-80.84313,{"facility":79,"status":8,"city":109,"state":110,"zip":111,"country":83,"geoPoint":112},"Maumee","Ohio","43537",{"lat":113,"lon":114},41.56283,-83.65382,{"facility":79,"status":8,"city":116,"state":117,"zip":118,"country":83,"geoPoint":119},"Nashville","Tennessee","37203",{"lat":120,"lon":121},36.16589,-86.78444,{"facility":79,"status":123,"city":124,"zip":125,"country":126,"geoPoint":127},"NOT_YET_RECRUITING","Asa Sul","70200-730","Brazil",{"lat":128,"lon":129},-15.82393,-47.9044,{"facility":79,"status":123,"city":131,"zip":132,"country":126,"geoPoint":133},"Goiás","74605-070",{"lat":134,"lon":135},-15.93444,-50.14028,{"facility":79,"status":123,"city":137,"zip":138,"country":126,"geoPoint":139},"Porto Alegre","90020-090",{"lat":140,"lon":141},-30.03283,-51.23019,{"facility":79,"status":123,"city":143,"zip":144,"country":126,"geoPoint":145},"Santo André","09060-650",{"lat":146,"lon":147},-23.66389,-46.53833,{"facility":79,"status":123,"city":149,"zip":150,"country":126,"geoPoint":151},"São Paulo","01317-000",{"lat":152,"lon":153},-23.5475,-46.63611,{"facility":155,"status":8,"city":156,"country":157},"Research Site Saint","Herblain","France",{"facility":79,"status":8,"city":159,"country":157,"geoPoint":160},"Rennes",{"lat":161,"lon":162},48.11109,-1.67431,{"facility":79,"status":8,"city":164,"country":165,"geoPoint":166},"Chiba","Japan",{"lat":167,"lon":168},35.6,140.11667,{"facility":79,"status":8,"city":170,"zip":171,"country":165,"geoPoint":172},"Kanagawa","241-8515",{"lat":173,"lon":174},37.58333,139.91667,{"facility":79,"status":8,"city":176,"zip":177,"country":165,"geoPoint":178},"Tokyo","104-0045",{"lat":179,"lon":180},35.6895,139.69171,{"facility":79,"status":8,"city":176,"zip":182,"country":165,"geoPoint":183},"135-8550",{"lat":179,"lon":180},{"facility":79,"status":8,"city":176,"zip":185,"country":165,"geoPoint":186},"142-8666",{"lat":179,"lon":180},{"facility":79,"status":8,"city":188,"country":189,"geoPoint":190},"Seongnam-si","South Korea",{"lat":191,"lon":192},37.43861,127.13778,{"facility":79,"status":8,"city":194,"zip":195,"country":189,"geoPoint":196},"Seoul","03722",{"lat":197,"lon":198},37.566,126.9784,{"facility":79,"status":8,"city":194,"zip":200,"country":189,"geoPoint":201},"06351",{"lat":197,"lon":198},{"facility":79,"status":8,"city":194,"zip":203,"country":189,"geoPoint":204},"3080",{"lat":197,"lon":198},{"facility":79,"status":8,"city":194,"country":189,"geoPoint":206},{"lat":197,"lon":198},{"facility":79,"status":8,"city":208,"country":209,"geoPoint":210},"Barcelona","Spain",{"lat":211,"lon":212},41.38879,2.15899,{"facility":79,"status":8,"city":214,"country":209,"geoPoint":215},"Madrid",{"lat":216,"lon":217},40.4165,-3.70256,{"facility":79,"status":8,"city":219,"country":209,"geoPoint":220},"Seville",{"lat":221,"lon":222},37.38283,-5.97317,{"facility":79,"status":8,"city":224,"country":225,"geoPoint":226},"Taichung","Taiwan",{"lat":227,"lon":228},24.1469,120.6839,{"facility":79,"status":8,"city":230,"country":225,"geoPoint":231},"Tainan",{"lat":232,"lon":233},22.99083,120.21333,{"facility":79,"status":8,"city":235,"zip":236,"country":225,"geoPoint":237},"Taipei","10002",{"lat":238,"lon":239},25.05306,121.52639,{"facility":79,"status":8,"city":235,"country":225,"geoPoint":241},{"lat":238,"lon":239},{"facility":79,"status":8,"city":243,"country":225,"geoPoint":244},"Taoyuan City",{"lat":245,"lon":246},24.99368,121.29696,[248],{"name":249,"role":250,"phone":251,"email":252},"Contact for Trial Information","CONTACT","908-992-6400","CTRinfo_us@daiichisankyo.com",[],[],[],{"nct_id":4,"conditions":257,"biomarkers":261},[258,259,260],"Breast Carcinoma","Lung Non-Small Cell Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":263,"summary":264,"prompt_version":274},true,{"design":265,"status":266,"heading":267,"summary":268,"follow_up":269,"word_count":270,"commitments":271,"compensation":272,"drugs_mentioned":273},"This is an interventional study designed to find the right dose and then further test the drug. It aims to enroll about 76 participants.","completed","Study of Subcutaneous Trastuzumab Deruxtecan for Metastatic Solid Tumors","This study is testing a drug called Trastuzumab Deruxtecan, given as a shot under the skin, for people with solid tumors that have spread (metastatic) or come back (recurrent). The main goals are to see how safe the drug is, what side effects it causes, and how much of it stays in the body. Researchers will also look at how well it works. You might be able to join if you are an adult aged 18 or older with metastatic solid tumors. For some cancers like breast cancer, you would need to have a specific marker called HER2 and have already received anti-HER2 treatment. The study plans to enroll about 76 participants, but its current status is unclear.","Participants will be monitored for side effects for up to 21 days after their last dose, for approximately 9 months.",118,"Not specified in the trial record.","Not stated in the trial record.",[34],"v2"]