No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
127 (estimated)
Sponsor
DualityBio Inc. · Industry
Who this trial is looking for
This trial is looking for patients with advanced or metastatic gastrointestinal cancer who have not responded to standard treatments. Participants will receive the study drug DB-1324 and help researchers learn more about its effects and safety.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with advanced or metastatic gastrointestinal cancer.
I have had progression of my cancer after standard treatments or cannot tolerate them.
I have at least one measurable tumor as confirmed by my doctor.
I expect to live for at least 3 more months.
I have a good performance status (ECOG 0-1).
My heart function is acceptable with LVEF of 50% or more.
My organ functions are normal.
I am willing to provide tumor samples for testing.
You may not be able to join if
I have received treatment that targets CDH17 before.
I have a history of significant gastrointestinal issues or bleeding.
I have uncontrolled heart disease.
I have had a stroke in the last 6 months.
I have a history of lung disease that required steroids.
I have ongoing active brain metastases.
I have unresolved side effects from previous cancer treatments.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.
Trial Locations
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City
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Status
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 ass…
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.
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