drugset / Trial / NCT07141706

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

NCT07141706 ↗

Phase 1 Recruiting 233 enrolled DualityBio Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes up to 3 randomized dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.

Timeline

Start
2025-09-23
Primary completion
2028-06
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject DB-1317 Unknown — Intravenous

Indications

No indication recorded.