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A Phase 1/2, Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of DB-1324 in Advanced or Metastatic Gastrointestinal Tumors
Led by DualityBio Inc. · Updated on 2026-05-22
127
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
D
DualityBio Inc.
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating DB-1324 in people with advanced or metastatic gastrointestinal tumors in a first-in-human Phase 1/2 clinical trial. The study aims to understand the safety, tolerability, how the drug moves and acts in the body, the maximum dose that can be tolerated, and the potential antitumor activity of DB-1324. This trial is open-label and multicenter, focusing on participants who have malignant GI tumors that have progressed after standard treatments or have no standard options. Participants will receive DB-1324 intravenously in multiple dosing schedules across different study parts. Phase 1 includes dose escalation, backfill, and dose expansion to find the maximum tolerated dose and recommended doses for later phases. Phase 2 will further explore safety and possible efficacy in selected GI tumor groups. Treatment continues until disease progression, unacceptable side effects, loss of benefit, participant withdrawal, or other stopping criteria. During the study, participants will have evaluations for adverse events, dose-limiting toxicities, and pharmacokinetic measures up to about 30 days after treatment. Researchers will also assess tumor response and survival outcomes over approximately three years. Participants will undergo tumor biopsies or provide archived tissue to measure biomarkers. Safety monitoring, including heart function and organ tests, will be part of the assessments throughout the study.
CONDITIONS
Brief Title
A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically documented advanced, unresectable, or metastatic gastrointestinal tumor
- Relapsed or progressed after standard treatments, intolerant to standard treatment, or no standard treatment available
- At least one measurable lesion per RECIST v1.1
- Life expectancy of at least 3 months
- ECOG performance status 0-1
- Left ventricular ejection fraction of 50% or higher within 28 days prior to enrollment
- Adequate organ function within 7 days before starting treatment
- Adequate washout period from prior treatments before starting study drug
- Willing to provide archived tumor tissue or undergo biopsy for biomarker analysis
- Other protocol-defined inclusion criteria apply
You will not qualify if you...
- Prior treatment with CDH17 targeted therapy
- Prior treatment with antibody-drug conjugate containing topoisomerase I inhibitor
- Chronic enteritis or inflammatory bowel disease
- Recent significant gastrointestinal bleeding within 1 month before first dose
- Clinically significant GI obstruction, perforation, or fistula within 6 months before first dose
- Uncontrolled or significant cardiovascular disease
- History of cerebrovascular accident or transient ischemic attack within 6 months before enrollment
- History or current interstitial lung disease or pneumonitis requiring steroids
- Lung-specific significant illnesses
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Active brain metastases
- Unresolved toxicities from prior anticancer therapy
- Other protocol-defined exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation (variable duration)
Participants receive multiple doses of DB-1324 administered intravenously until disease progression, unacceptable toxicity, or other discontinuation criteria are met.
Repeated visits for treatment administration and assessments during treatment
Duration - Approximately 30 days post-treatment
Participants are monitored for safety and treatment effects for approximately 30 days after treatment ends.
1 to 2 safety follow-up visits (in-person)
Trial Site Locations
Total: 9 locations
1
USA05-0
Port Saint Lucie, Florida, United States, 34952
Actively Recruiting
2
USA02-0
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
USA01-0
Huntersville, North Carolina, United States, 28078
Actively Recruiting
4
USA03-0
Cincinnati, Ohio, United States, 45219
Actively Recruiting
5
AUS02-0
Randwick, New South Wales, Australia, 2031
Actively Recruiting
6
AUS03-0
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
7
AUS01-0
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
8
CHN01-0
Beijing, China, 100142
Actively Recruiting
9
CHN04-0
Beijing, China, 102206
Actively Recruiting
Research Team
Z
Zhaochuan Wang
Y
Yuanyuan Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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