A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Gastrointestinal Cancer

In brief

This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.

Key facts

Study ID

NCT07263594

Run by

DualityBio Inc.

People needed

127

Starts

2026-01-20

Expected to finish

2028-12-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically documented advanced/unresectable, or metastatic GI tumor.
• Have relapsed or progressed on or after standard systemic treatments, or are intolerant to standard treatment, or for which no standard treatment is available.
• At least one measurable lesion as assessed by the investigator according to response evaluation criteria in RECIST v1.1.
• Has a life expectancy of ≥ 3 months.
• Has an ECOG PS of 0-1.
• Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.
• Has adequate organ functions within 7 days prior to Day 1 of Cycle 1.
• Has an adequate treatment washout period before Day 1 of Cycle 1.
• Participants are willing to provide archived tumor tissue or undergo a tumor biopsy for the measurement of CDH17 levels and other biomarkers.
• Other protocol-defined Inclusion criteria apply.

You may not qualify if…

• Prior treatment with CDH17 targeted therapy.
• Prior treatment with ADC with topoisomerase I inhibitor.
• Has chronic enteritis or inflammatory bowel disease. Or has clinically significant bleeding of GI tract or adjacent organs within 1 month prior to the first dose of study treatment. Or has clinically significant obstruction and/or perforation and/or fistulae (including prior GI fistula operation) of GI tract or adjacent tissues within 6 months prior to the first dose of study treatment.
• Uncontrolled or significant cardiovascular disease.
• Has a medical history of cerebrovascular accident including transient ischemic attack within 6 months before enrollment.
• Has a history of (non-infectious) ILD/pneumonitis that required steroids, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• Have a lung-specific intercurrent clinically significant illness.
• Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.
• Has clinically active brain metastases.
• Has unresolved toxicities from previous anticancer therapy.
• Other protocol-defined Exclusion criteria apply.

Where it is running

• USA05-0 — Port Saint Lucie, Florida, United States (enrolling)
• USA02-0 — Grand Rapids, Michigan, United States (enrolling)
• USA01-0 — Huntersville, North Carolina, United States (enrolling)
• USA03-0 — Cincinnati, Ohio, United States (enrolling)
• AUS02-0 — Randwick, New South Wales, Australia (enrolling)
• AUS03-0 — South Brisbane, Queensland, Australia (enrolling)
• AUS01-0 — Nedlands, Western Australia, Australia (enrolling)
• CHN01-0 — Beijing, China (enrolling)
• CHN04-0 — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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