[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her-2-positive-advanced-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her-2-positive-advanced-solid-tumors":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100512829",false,"NCT05957536","A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors","A Phase 1, Open-label Dose Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors.","Inclusion Criteria:\n\n* Subject must have documented HER2 positivity (determined by immunohistochemistry \\[IHC\\], in situ hybridization \\[ISH\\], Next Generation Sequencing \\[NGS\\] or other analysis techniques as appropriate).\n* Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Subject must have left ventricular ejection fraction (LVEF) ≥50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within the screening period.\n* Subject must have adequate organ and marrow function within the screening period.\n\nExclusion Criteria:\n\n* Subject has any prior treatment with anti-CD47 or SIRPα agent.\n* Subject has any prior treatment without adequate washout periods as defined in the protocol.\n* Subject has immunosuppressive medication that is not completed 14 days before the first dose of study medication.\n* Subject has uncontrolled intercurrent illness that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.\n* Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).\n* Judgment by the Investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions, and requirements.","ALL","18 Years",{"count":18,"type":19},128,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors.",[25],"HER-2 Positive Advanced Solid Tumors",[27,28],"HER-2 Positive","Advanced Solid Tumors","RECRUITING","2026-03-11",{"date":32,"type":33},"2026-03-13","ACTUAL",{"date":35,"type":33},"2023-09-19",{"date":37,"type":19},"2028-12-19",{"name":39,"class":40},"D3 Bio (Wuxi) Co., Ltd","INDUSTRY",9,""]