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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 one randomized dose expansion cohort and two single-arm 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
253
Start Date
2025-09-23
Completion Date
2028-06
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
DB-1317
Administered I.V.
Locations (14)
USA04-0
Los Angeles, California, United States
USA05-0
Ann Arbor, Michigan, United States
Site USA06-0
Pittsburgh, Pennsylvania, United States
USA02-0
Houston, Texas, United States
USA03-0
San Antonio, Texas, United States
USA01-0
Fairfax, Virginia, United States
AUS03-0
Liverpool, New South Wales, Australia
AUS01-0
Randwick, New South Wales, Australia
AUS04-0
Westmead, New South Wales, Australia
AUS02-0
Nedlands, Western Australia, Australia
Chn01-1/Chn01-2
Guangzhou, Guangdong, China
CHN05-0
Harbin, Heilongjiang, China
CHN03-0
Zhengzhou, Henan, China
CHN04-0
Jinan, Shandong, China