First-in-Human Phase 1a1b Study of DB-1317 Given by Intravenous Infusion to Evaluate Safety and Early Effectiveness in Adults With Selected Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are conducting a multicenter, open-label Phase 1a1b study to evaluate DB-1317 in adults with selected advanced or metastatic solid tumors that have relapsed or progressed after standard treatments. The study aims to identify the maximum tolerated dose MTD or maximum administered dose MAD of DB-1317 and to assess its safety, tolerability, and preliminary effectiveness in specific tumor types including gastric, colorectal, and pancreatic cancers. In Phase 1a, increasing doses of DB-1317 will be given every three weeks using an accelerated titration design initially, followed by a Bayesian optimal interval design with safety monitoring. If the MTD or MAD is confirmed, alternative dosing every two weeks may be explored. Phase 1b involves one randomized dose expansion cohort and two single-arm expansion cohorts enrolling participants with selected tumor types based on earlier findings. Approximately 160 participants will be enrolled in Phase 1b at doses determined from Phase 1a data. Participants will receive DB-1317 by intravenous infusion on Day 1 of each treatment cycle lasting 21 days. Safety will be closely monitored including dose-limiting toxicities and adverse events. Investigations will include tumor assessments by RECIST criteria, biomarker analysis from tumor samples, pharmacokinetics, immunogenicity, and overall treatment response. Follow-up will continue for about one year post-treatment to evaluate safety and anti-tumor activity.

A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors