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New treatment option for Gastrointestinal Cancer
Official title A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors
ClinicalTrials.gov ID: NCT07263594
What this study is testing
What is DB-1324?
DB-1324 is an investigational medicine, being studied as a potential treatment for gastrointestinal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility 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 apply.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Port Saint Lucie, Florida, United States
- Grand Rapids, Michigan, United States
- Huntersville, North Carolina, United States
- Cincinnati, Ohio, United States
- Randwick, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Nedlands, Western Australia, Australia
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Port Saint Lucie, Florida, United States; Grand Rapids, Michigan, United States; Huntersville, North Carolina, United States; Cincinnati, Ohio, United States; Randwick, New South Wales, Australia; South Brisbane, Queensland, Australia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.