Objective:
Phase 1 (Dose Escalation)
Primary Objectives:
- To evaluate the safety and tolerability of DB-1305 in subjects with advanced solid tumors.
- To determine the MTD and/or the RP2D of DB-1305.
Secondary Objectives:
- To assess the preliminary antitumor activity of DB-1305.
- To characterize the Pharmacokinetics (PK) of DB-1305 (DB-1305 antibodydrug conjugate [ADC], total anti- Trop-2 antibody, unconjugated payload P1021).
- To assess the immunogenicity of DB-1305 in targeted subjects.
Phase 2a (Dose Expansion)
Primary Objectives:
- To assess the safety and tolerability of DB-1305 in targeted subject populations.
- To assess the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for DB1305 in subjects with select advanced solid tumors
Secondary Objectives:
- To further assess the PK of DB-1305 (DB-1305 ADC, total anti-Trop2 antibody, unconjugated payload P1021.
- To evaluate the prevalence of anti-drug antibody (ADA) against DB-1305 in serum via a validated assay.
- To evaluate the preliminary efficacy of DB-1305 with additional efficacy parameters.