Clinical Trial

First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors

Active, Not Recruiting Phase 1/2
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Summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305/BNT325 in subjects with advanced solid tumors.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2022-06-24; most recent amendment 2026-05-08.
Status change: Recruiting → Active, Not Recruiting 2026-05-08
Status change: Not Yet Recruiting → Recruiting 2022-11-07
Trial Details
NCT Number NCT05438329
Lead Sponsor DualityBio Inc.
Collaborators: BioNTech SE
Conditions Advanced Solid Tumor
Enrollment 1,123 participants
Start Date 2022-07-19
Primary Completion 2027-08-13 (estimated)
Study Completion 2027-09-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-12