Phase 12a Study to Evaluate Safety and Preliminary Effectiveness of DB-1310, Alone or With Other Drugs, in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of DB-1310 in adults with advanced or metastatic solid tumors in this Phase 12a multicenter, open-label study. The trial explores DB-1310 both alone and in combination with other cancer drugs such as trastuzumab, trastuzumab biosimilars, osimertinib, or capecitabine. This study aims to find the best doses and gather early evidence about the drugs effects on different solid tumors. The study begins with a Phase 1 dose-escalation part using a standard design to find the maximum tolerated dose and recommended Phase 2 dose of DB-1310 alone and in combination with other treatments. Participants receive DB-1310 as a single intravenous dose on Day 1 of each 3-week cycle at different dose levels. Phase 2a expands dosing to confirm safety and tolerability and explore efficacy in selected tumor types with similar dosing schedules and drug combinations. Participants will be closely monitored through tumor assessments, safety evaluations, and laboratory tests during treatment cycles lasting 21 days each. Researchers measure outcomes including dose-limiting toxicities, adverse events, tumor response per established criteria, and pharmacokinetic properties. Follow-up extends up to one year post-treatment to observe long-term safety and treatment effects. The total duration and schedule of visits depend on individual treatment cycles and response.

A Study of DB-1310 in Advanced/Metastatic Solid Tumors