DB-1324 for Gastrointestinal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called DB-1324 for individuals with advanced gastrointestinal (GI) cancer. The researchers aim to determine the safety and effectiveness of DB-1324 by testing various dose levels. Participants should have GI cancer that has returned or worsened after standard treatments or lack other treatment options. This study suits those who can identify at least one measurable tumor and have a life expectancy of at least three months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires an adequate treatment washout period (time without taking certain medications) before starting the study, but it doesn't specify which medications need to be stopped. It's best to discuss your current medications with the trial team to get specific guidance.
Is there any evidence suggesting that DB-1324 is likely to be safe for humans?
Research shows that DB-1324 is currently being tested for safety and effectiveness in treating gastrointestinal cancer. This marks the first human trial of DB-1324, so limited information exists on how people tolerate it. As the trial is in its early stages, comprehensive safety data is not yet available.
DB-1324 is developed using DualityBio's proprietary technology, which has proven successful in other treatments. This success suggests potential safety, but confirmation is needed specifically for DB-1324. The trial will explore various doses to determine the safest and most effective amount.
Participants in early studies like this help researchers identify possible side effects. While DB-1324 is hoped to be beneficial, careful monitoring is crucial to fully understand its safety.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for gastrointestinal cancer, such as chemotherapy, surgery, and radiation, DB-1324 is unique because it targets cancer cells in a novel way. Researchers are excited about DB-1324 because it employs a new mechanism of action that could improve efficacy and safety compared to existing options. Additionally, the ability to explore different dosing regimens in early phases offers the potential to fine-tune its effectiveness and minimize side effects, making this treatment a promising candidate for those who have tried other therapies.
What evidence suggests that DB-1324 might be an effective treatment for gastrointestinal cancer?
Research shows that DB-1324 targets a protein called CDH17, often found in cancers of the digestive system, such as colorectal, pancreatic, and stomach cancers. This protein aids cancer cell growth and spread, so blocking it could slow or stop the cancer. Early studies suggest that DB-1324, which employs a special method to attack cancer cells, shows promise in fighting these cancers. In this trial, participants will receive DB-1324 in various phases, including dose escalation, dose expansion, and backfill, to explore its preliminary efficacy and safety. The drug is being developed with the hope of becoming a leading treatment in its field. Although current evidence is still developing, focusing on a specific target like CDH17 gives scientists a strong reason to believe in its potential.26789
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Dose Escalation
Participants receive a single-dose of DB-1324 at different dose levels to determine the maximum tolerated dose (MTD) and recommended dose for expansions (RDEs)
Phase 1: Backfill
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 safety, efficacy, PK, and pharmacodynamics
Phase 1: Dose Expansion
Two or more appropriate dose regimens of DB-1324 will be explored for preliminary efficacy and safety
Phase 2
Phase 2 will confirm the safety, tolerability, and explore efficacy in selected malignant GI tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
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Treatment groups
Experimental Treatment
Phase 2 will consist of one or more cohorts intended to confirm early signals of efficacy identified in Phase 1.
Enrolled Subjects will receive a single-dose of DB-1324 at different Dose Level or different dose regimen
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.
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
GlaxoSmithKline
Industry Sponsor
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
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT07263594?term=physio+OR+physical+therapy+OR+exercise+therapy+OR+physiotherapyA Study of DB-1324 in Advanced/Metastatic ...
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2 study to explore the safety, tolerability, and efficacy of DB-1324 in ...
2.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-db-1324-in-advanced-metastatic-gastrointestinal-tumorsA Study of DB-1324 in Advanced/Metastatic Gastrointestinal ...
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose ...
3.
adcreview.com
adcreview.com/business-economics/gsk-and-duality-biologics-sign-option-agreement-for-db-1324/GSK and Duality Biologics Sign Option Agreement for DB- ...
GSK and Duality Biologics have entered into an exclusive option agreement for developing and commercializing DB-1324, a potentially best-in-class antibody-drug ...
CDH17 becomes flavour of the month | ApexOnco
Targeting CDH17 is said to have utility in GI cancers, especially colorectal, pancreatic and gastric, though some groups also claim CDH17 ...
5.
biopharmaboardroom.com
biopharmaboardroom.com/news/49/2599/duality-biologics-signs-exclusive-option-agreement-with-gsk-for-adc-candidate-db-1324-in-gastrointestinal-cancer.htmlDuality Biologics Signs Exclusive Option Agreement with ...
DB-1324 is an ADC candidate built with DualityBio's proprietary and clinically validated Duality Immune Toxin Antibody Conjugate (DITAC) ...
A Study of DB-1324 in Advanced/Metastatic ...
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, ...
Duality Biologics and GSK Enter Exclusive Option ...
DB-1324 is an ADC candidate built with DualityBio's proprietary and clinically validated Duality Immune Toxin Antibody Conjugate (DITAC) ...
Safety and biological outcomes following a phase 1 trial of ...
Safety and biological outcomes following a phase 1 trial of GD2-specific CAR-T cells in patients with GD2-positive metastatic melanoma and other solid cancers.
9.
bioworld.com
bioworld.com/articles/714947-gsk-inks-1b-option-agreement-for-dualitybio-preclinical-adc-candidateGSK inks $1B option agreement for Dualitybio preclinical ...
DB-1324 is an ADC candidate built with Dualitybio's Duality Immune Toxin Antibody Conjugate (DITAC) platform. In preclinical development, the ...
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