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.
Subject must have documented HER2 positivity (determined by immunohistochemistry [IHC], in situ hybridization [ISH], Next Generation Sequencing [NGS] or other analysis techniques as appropriate).
Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subject must have left ventricular ejection fraction (LVEF) ≥50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within the screening period.
Subject must have adequate organ and marrow function within the screening period.
Subject has any prior treatment with anti-CD47 or SIRPα agent.
Subject has any prior treatment without adequate washout periods as defined in the protocol.
Subject has immunosuppressive medication that is not completed 14 days before the first dose of study medication.
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.
Sequential
D3L-001
Biological/VaccineIntravenous administration
Number of Participants With Adverse Events (AEs)
Maximum Tolerated Dose based on Dose-Limiting Toxicities (DLTs)
D3L-001 minimum serum concentration (Ctrough)
D3L-001 maximum observed plasma concentration (Cmax)
D3L-001 time to maximum plasma concentration (tmax)
D3L-001 half-life (t1/2)
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