RecruitingPhase 1Phase 2NCT07263594
A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors
A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1324 in Participants With Advanced/Metastatic Gastrointestinal Tumors
Sponsor
DualityBio Inc.
Enrollment
127 participants
Start Date
Jan 20, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria9
- 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.
Exclusion Criteria10
- 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.
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Interventions
DRUGDB-1324
Administered I.V.
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07263594
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