NCT07263594 A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors
| NCT ID | NCT07263594 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | DualityBio Inc. |
| Condition | Gastrointestinal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 127 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 127 participants in total. It began in 2026-01-20 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Lily Hu
STUDY DIRECTOR
DualityBio Inc.
Frequently Asked Questions
Who can join the NCT07263594 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07263594 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07263594 currently recruiting?
Yes, NCT07263594 is actively recruiting participants. Contact the research team at zhaochuan.wang@dualitybiologics.com for enrollment information.
Where is the NCT07263594 trial being conducted?
This trial is being conducted at Port Saint Lucie, United States, Grand Rapids, United States, Huntersville, United States, Cincinnati, United States and 5 additional locations.
Who is sponsoring the NCT07263594 clinical trial?
NCT07263594 is sponsored by DualityBio Inc.. The principal investigator is Lily Hu at DualityBio Inc.. The trial plans to enroll 127 participants.
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