First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
Trial Parameters
Brief Summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305/BNT325 in subjects with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: * Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent). * Histologically or cytologically confirmed unresectable advanced/ metastatic solid tumors who have relapsed or progressed on or after standard systemic treatments or for which no standard treatment is available. * At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. * Has a life expectancy of ≥ 3 months. * Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1. * Has Left Ventricular Ejection Fraction (LVEF) ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment. * Has adequate organ functions within 7 days prior to Day 1 of Cycle 1. * Has adequate treatment washout period prior to Day 1 of Cycle 1. * Is willing to provide pre-existing resected tumor samples or undergo fresh tum