DB-1324 for Gastrointestinal Cancer
Not yet recruiting at 5 trial locations
YS
Overseen ByYuanyuan Sun
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: DualityBio Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.
Who Is on the Research Team?
LH
Lily Hu
Principal Investigator
DualityBio Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with advanced or metastatic gastrointestinal tumors. Specific eligibility criteria are not provided, but typically participants must have a confirmed diagnosis and may need to meet certain health standards.Inclusion Criteria
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 LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment
See 7 more
Exclusion Criteria
Other protocol-defined Exclusion criteria apply
I have been treated with CDH17 targeted therapy before.
I have been treated with an ADC that targets topoisomerase I.
See 10 more
What Are the Treatments Tested in This Trial?
Interventions
- DB-1324
Trial Overview The study is testing DB-1324's safety, how well it's tolerated by patients, how the body processes it (pharmacokinetics), how it affects the body (pharmacodynamics), its maximum safe dose, and its effectiveness against tumors.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: DB-1324 Phase 2Experimental Treatment1 Intervention
Phase 2 will consist of one or more cohorts intended to confirm early signals of efficacy identified in Phase 1.
Group II: DB-1324 Phase 1 Dose escalationExperimental Treatment1 Intervention
Enrolled Subjects will receive a single-dose of DB-1324 at different Dose Level or different dose regimen
Group III: DB-1324 Phase 1 Dose ExpansionExperimental Treatment1 Intervention
Two or more appropriate dose regimens of DB-1324, determined from the emerging dose escalation (and backfill) data, will be explored for preliminary efficacy and safety of DB-1324.
Group IV: DB-1324 Phase 1 BackfillExperimental Treatment1 Intervention
Participants with GI cancers who have received no more than 3 prior lines of systemic therapy may be backfilled at the selected dose regimens to further explore the safety, efficacy, PK, and pharmacodynamics of DB-1324.
Find a Clinic Near You
Who Is Running the Clinical Trial?
DualityBio Inc.
Lead Sponsor
Trials
12
Recruited
5,800+
GlaxoSmithKline
Industry Sponsor
Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Other People Viewed
By Subject
By Trial
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.