A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced/Metastatic Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT07141706
- Run by
- DualityBio Inc.
- People needed
- 253
- Starts
- 2025-09-23
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- USA04-0 — Los Angeles, California, United States (enrolling)
- USA05-0 — Ann Arbor, Michigan, United States (enrolling)
- Site USA06-0 — Pittsburgh, Pennsylvania, United States (enrolling)
- USA02-0 — Houston, Texas, United States (enrolling)
- USA03-0 — San Antonio, Texas, United States (enrolling)
- USA01-0 — Fairfax, Virginia, United States (enrolling)
- AUS03-0 — Liverpool, New South Wales, Australia (enrolling)
- AUS01-0 — Randwick, New South Wales, Australia (enrolling)
- AUS04-0 — Westmead, New South Wales, Australia (enrolling)
- AUS02-0 — Nedlands, Western Australia, Australia (enrolling)
- Chn01-1/Chn01-2 — Guangzhou, Guangdong, China (enrolling)
- CHN05-0 — Harbin, Heilongjiang, China (enrolling)
- CHN03-0 — Zhengzhou, Henan, China (enrolling)
- CHN04-0 — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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