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Municipality","200025",{"type":73,"coordinates":141},[142,143],121.45806,31.22222,{"lat":143,"lon":142},{"facility":65,"status":66,"city":146,"state":147,"zip":148,"country":129,"countryCode":130,"cosmosGeoPoint":149,"geoPoint":153,"contacts":11},"Hangzhou","Zhejiang","310022",{"type":73,"coordinates":150},[151,152],120.16142,30.29365,{"lat":152,"lon":151},{"type":155,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":165,"type":166},128,"ESTIMATED","INTERVENTIONAL",[169],"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.",[172],"HER-2 Positive Advanced Solid Tumors",[174,175],"HER-2 Positive","Advanced Solid Tumors","2026-03-11",{"date":178,"type":179},"2026-03-13","ACTUAL",{"date":181,"type":179},"2023-09-19",{"date":183,"type":166},"2028-12-19",{"name":5,"class":6},9]