First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors

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 tumor biopsy for the measurement of Trop-2 level and other biomarkers if not contraindicated.
• •Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.