A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors (NCT07263594) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors
United States, Australia, China127 participantsStarted 2026-01-20
Plain-language summary
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Escalation and Backfill parts: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Timeframe: Up to safety follow-up visit, approximately 30 days post-treatment
2
Dose Escalation and Backfill parts: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Timeframe: Up to safety follow-up visit, approximately 30 days post-treatment
3
Dose Escalation and Backfill parts: Percentage of participants with Treatment Emergent Adverse Events (TEAEs) , Grade ≥ 3 TEAE, TEAE leading to dose reduction/interruption/discontinuation
Timeframe: Up to safety follow-up visit, approximately 30 days post-treatment
4
Dose Escalation and Backfill parts: Maximum Tolerated Dose(MTD) of DB-1324
Timeframe: Up to safety follow-up visit, approximately 30 days post-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.