NCT07263594 · DualityBio Inc.
A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors
What this study is about
This study, the first clinical trial, aims to determine the safety, tolerability, how the drug moves through the body, how the drug affects the body, maximum tolerated dose, and antitumor activity of DB-1324.
View original scientific description
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.
Interventions
DRUG
DB-1324
Administered I.V.
Primary outcome measures
Dose Escalation and Backfill parts: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Time frame: Up to safety follow-up visit, approximately 30 days post-treatment
Percentage of participants in dose escalation and backfill parts with DLTs
Dose Escalation and Backfill parts: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time frame: Up to safety follow-up visit, approximately 30 days post-treatment
Percentage of participants with SAEs in dose escalation and backfill parts graded according to NCI CTCAE v5.0
Dose Escalation and Backfill parts: Percentage of participants with Treatment Emergent Adverse Events (TEAEs) , Grade ≥ 3 TEAE, TEAE leading to dose reduction/interruption/discontinuation
Time frame: Up to safety follow-up visit, approximately 30 days post-treatment
Percentage of participants who experienced any of the above TEAEs in dose escalation and backfill parts graded according to NCI CTCAE v5.0
Dose Escalation and Backfill parts: Maximum Tolerated Dose(MTD) of DB-1324
Time frame: Up to safety follow-up visit, approximately 30 days post-treatment
MTD will be determined by evaluating the incidence of DLTs during the DLT assessment period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Participants are willing to provide archived tumor tissue or undergo a tumor biopsy for the measurement of CDH17 levels and other biomarkers.
- Other protocol-defined Inclusion criteria apply.
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.
- 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.
- Other protocol-defined Exclusion criteria apply.
Where
- Port Saint Lucie, Florida
- Grand Rapids, Michigan
- Huntersville, North Carolina
- Cincinnati, Ohio
Collaborators
GlaxoSmithKline
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations