Clinical Trial

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

Recruiting Phase 1/2
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Record status
This record was last updated January 28, 2026 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
Protocol Amendment History 26 amendments
This ClinicalTrials.gov record has been amended 26 times since 2021-11-26; most recent amendment 2026-01-27.
Status change: Not Yet Recruiting → Recruiting 2022-02-03
Trial Details
NCT Number NCT05150691
Lead Sponsor DualityBio Inc.
Collaborators: BioNTech SE
Conditions HER2-positive Advanced Solid Tumor
Enrollment 796 participants
Start Date 2022-01-31
Primary Completion 2026-04 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-28