[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-positive-advanced-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-positive-advanced-solid-tumor":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100450837","phase-1-a-phase-12a-study-of-db-1303bnt323-in-advancedmetastatic-solid-tumors-100450837",false,"NCT05150691","A Phase 1\u002F2a Study of DB-1303\u002FBNT323 in Advanced\u002FMetastatic Solid Tumors","A Phase 1\u002F2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303\u002FBNT323 in Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced\u002Funresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.\n* At least 1 measurable lesion (per RECIST 1.1)\n* Provide signed informed consent\n* ECOG performance status (PS) of 0-1.\n* LVEF ≥ 50% by ECHO or MUGA\n* Adequate organ functions\n* Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.\n* Life expectancy of ≥ 3 months.\n\nAdditional Inclusion Criteria for Part 2 Expansion Group 9:\n\n1\\. Has pathologically documented advanced\u002Funresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced\u002Funresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line.\n\nExclusion Criteria:\n\n* History of symptomatic CHF (New York Heart Association \\[NYHA\\] classes II-IV) or serious cardiac arrhythmia requiring treatment.\n* History of myocardial infarction or unstable angina within 6 months before Day 1.\n* Average QTcF \\> 450 ms in males and \\> 470 ms in females\n* History of clinically significant lung diseases\n* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.\n* HIV infection with AIDS defining illness or active viral hepatitis.\n* Clinically active brain metastases\n* Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.\n* A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.\n* Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.","ALL","18 Years",{"count":19,"type":20},796,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a dose-escalation and dose-expansion Phase 1\u002F2a trial to evaluate the safety and tolerability of DB-1303\u002FBNT323 in subjects with advanced solid tumors that express HER2.",[27],"HER2-positive Advanced Solid Tumor",[29,30,31,32,33,34,27,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57],"HER2","HER2-positive","HER2-positive Breast Cancer","HER2-positive Gastric Cancer","HER2-positive Endometrial Cancer","HER2-positive Biliary Tract Cancer","HER2 low","HER2 high","metastatic cancer","HER2-positive GEJ","Uterine serous papillary carcinoma","USPC","recurrent cancer","carcinoma","neoplasms","breast neoplasms","gastrointestinal neoplasms","endometrial neoplasms","biliary tract neoplasms","Antineoplastic Agents, Biological","stomach cancer","bile duct cancer","Cholangiocarcinoma","liver cancer","liver neoplasms","NSCLC","Non-Small Cell Lung Cancer","NSCLC HER2 mutation","HER2 Low Breast Cancer","RECRUITING","2026-01-27",{"date":61,"type":62},"2026-01-28","ACTUAL",{"date":64,"type":62},"2022-01-31",{"date":66,"type":20},"2027-10",{"name":68,"class":69},"DualityBio Inc.","INDUSTRY",102,"HER2-Positive Advanced Solid Tumor"]