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Clinical Trials in China / NCT07263594
Recruiting Phase 1/2

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

NCT07263594 · tracked via the Priya Life Science China tracker
Sponsor
DualityBio Inc.
Phase
Phase 1/2
Started
2026-01-20
Last updated
2026-05-22

Condition(s) studied

Gastrointestinal Cancer

Investigational drug(s) / intervention(s)

DB-1324

DB-1324: Administered I.V.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Pathologically documented advanced/unresectable, or metastatic GI tumor. 2. Have relapsed or progressed on or after standard systemic treatments, or are intolerant to standard treatment, or for which no standard treatment is available. 3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in RECIST v1.1. 4. Has a life expectancy of ≥ 3 months. 5. Has an ECOG PS of 0-1. 6. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment. 7. Has adequate organ functions within 7 days prior to Day 1 of Cycle 1. 8. Has an adequate treatment washout period before Day 1 of Cycle 1. 9. Participants are willing to provide archived tumor tissue or undergo a tumor biopsy for the measurement of CDH17 levels and other biomarkers. 10. Other protocol-defined Inclusion criteria apply. Exclusion Criteria: 1. Prior treatment with CDH17 targeted therapy. 2. Prior treatment with ADC with topoisomerase I inhibitor. 3. 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. 4. Uncontrolled or significant cardiovascular disease. 5. Has a medical history of cerebrovascular accident including transient ischemic attack within 6 months before enrollment. 6. 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. 7. Have a lung-specific intercurrent clinically significant illness. 8. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals. 9. Has clinically active brain metastases. 10. Has unresolved toxicities from previous anticancer therapy. 11. Other protocol-defined Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
USA05-0 Port Saint Lucie Florida Recruiting
USA02-0 Grand Rapids Michigan Recruiting
USA01-0 Huntersville North Carolina Recruiting
USA03-0 Cincinnati Ohio Recruiting
AUS02-0 Randwick New South Wales Recruiting
AUS03-0 South Brisbane Queensland Recruiting
AUS01-0 Nedlands Western Australia Recruiting
CHN01-0 Beijing China Recruiting
CHN04-0 Beijing China Recruiting

More DualityBio Inc. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07263594 on ClinicalTrials.gov ↗ ← All trials in China