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A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
Sponsor: DualityBio Inc.
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.
Official title: A Phase 1a/1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants With Selected Advanced/Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
233
Start Date
2025-09-23
Completion Date
2028-06
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
DB-1317
Administered I.V.
Locations (6)
USA04-0
Los Angeles, California, United States
Site USA06-0
Pittsburgh, Pennsylvania, United States
USA02-0
Houston, Texas, United States
USA03-0
San Antonio, Texas, United States
USA01
Fairfax, Virginia, United States
AUS01-0
Randwick, New South Wales, Australia