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.
D3 Bio (Wuxi) Co., Ltd
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Subject…
Interventions
- BiologicalD3L-001
Intravenous administration
Locations (9)
- D3 Bio Investigative SiteStanford, California
- D3 Bio Investigative SiteBoston, Massachusetts
- D3 Bio Investigative SiteNew York, New York
- D3 Bio Investigative SiteSan Antonio, Texas
- D3 Bio Investigative SiteSydney, New South Wales
- D3 Bio Investigative SiteMalvern, Victoria