DB-1324 in advanced gastrointestinal tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label phase 1/2 trial of DB-1324 in patients with malignant GI tumors. Phase 1 uses dose escalation and expansion to identify the maximum tolerated dose and recommended phase 2 dose, while Phase 2 assesses safety and preliminary efficacy in selected GI tumor types. Participants receive DB-1324 until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Eligibility requires measurable disease, adequate organ function, and prior treatment experience or lack of standard options. The study is sponsored by DualityBio with GlaxoSmithKline collaborating, at sites in Florida, Michigan, and North Carolina.

Why it matters

Who can join: the full rules

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.

Where it's running

• Usa05-0
  Port Saint Lucie, Florida, United States Recruiting
• Usa02-0
  Grand Rapids, Michigan, United States Recruiting
• Usa01-0
  Huntersville, North Carolina, United States Recruiting
• Usa03-0
  Cincinnati, Ohio, United States Recruiting
• Aus02-0
  Randwick, New South Wales, Australia Recruiting
• Aus03-0
  South Brisbane, Queensland, Australia Recruiting

Study contacts

• Study coordinator: Zhaochuan Wang
• Email: zhaochuan.wang@dualitybiologics.com
• Phone: 4123279868

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.