A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors
Start Date
1/20/2026
Completion Date
12/1/2028
Summary
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.
Detailed Description
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2 study to explore the safety, tolerability, and efficacy of DB-1324 in participants with malignant GI tumors. The Phase 1, which includes Dose Escalation, Backfill, and Dose Expansion to identify the MTD and determine the RDEs and RP2D. Phase 2 will confirm the safety, tolerability, and explore efficacy in selected malignant GI tumors. For both Phase 1 and Phase 2, participants will receive study treatment until 1) disease progression, 2) loss of clinical benefit in the opinion of the investigator, 3) unacceptable toxicity, 4) withdrawal from study treatment by participant, 5) lost to follow up, or 6) another criterion for discontinuation is met, whichever occurs first.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
DB-1324
Conditions
Locations
USA05-0
Port Saint Lucie, Florida 34952
United States
USA02-0
Grand Rapids, Michigan 49546
United States
USA01-0
Huntersville, North Carolina 28078
United States
USA03-0
Cincinnati, Ohio 45219
United States
AUS02-0
Randwick, New South Wales 2031
Australia
AUS03-0
South Brisbane, Queensland 4101
Australia
AUS01-0
Nedlands, Western Australia 6009
Australia
CHN01-0
Beijing, 100142
China
CHN04-0
Beijing, 102206
China