Gastrointestinal CancerPhase 1/2NCT07263594
A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors
A Phase 1/2 study testing DB-1324 in people with Gastrointestinal Cancer, run by DualityBio Inc. at 9 sites in 3 countries.
Trial summary
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- DB-1324
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 20 Jan 2026to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 Inclusion criteria apply.
Who cannot join
- 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 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.
- 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.
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- 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.
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Yuanyuan Sun contact
9 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
USA03-0
Cincinnati, Ohio, 45219
- Recruiting
USA02-0
Grand Rapids, Michigan, 49546
- Recruiting
USA01-0
Huntersville, North Carolina, 28078
- Recruiting
USA05-0
Port Saint Lucie, Florida, 34952
Australia3 sites, 3 recruiting
- Recruiting
AUS01-0
Nedlands, Western Australia, 6009
- Recruiting
AUS02-0
Randwick, New South Wales, 2031
- Recruiting
AUS03-0
South Brisbane, Queensland, 4101
China2 sites, 2 recruiting
- Recruiting
CHN01-0
Beijing, 100142
- Recruiting
CHN04-0
Beijing, 102206
About this study
Official title: A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1324 in Participants With Advanced/Metastatic Gastrointestinal Tumors
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.
Read the detailed description
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2 study to explore the safety, tolerability, and efficacy of DB-1324 in participants with malignant GI tumors.
The Phase 1, which includes Dose Escalation, Backfill, and Dose Expansion to identify the MTD and determine the RDEs and RP2D.
Phase 2 will confirm the safety, tolerability, and explore efficacy in selected malignant GI tumors.
For both Phase 1 and Phase 2, participants will receive study treatment until 1) disease progression, 2) loss of clinical benefit in the opinion of the investigator, 3) unacceptable toxicity, 4) withdrawal from study treatment by participant, 5) lost to follow up, or 6) another criterion for discontinuation is met, whichever occurs first.
- Conditions
- Gastrointestinal Cancer
- Being tested
- DB-1324
- Keywords
- Gastrointestinal Tumors, DB-1324
- Medical subject headings
- Gastrointestinal Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB-1324Drug
Administered I.V.
| Study group | Role | What they receive |
|---|---|---|
| DB-1324 Phase 1 Dose escalation | Experimental | Enrolled Subjects will receive a single-dose of DB-1324 at different Dose Level or different dose regimen Receives: Drug: DB-1324 |
| DB-1324 Phase 1 Backfill | Experimental | 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. Receives: Drug: DB-1324 |
| DB-1324 Phase 1 Dose Expansion | Experimental | 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. Receives: Drug: DB-1324 |
| DB-1324 Phase 2 | Experimental | Phase 2 will consist of one or more cohorts intended to confirm early signals of efficacy identified in Phase 1. Receives: Drug: DB-1324 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation and Backfill parts: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Percentage of participants in dose escalation and backfill parts with DLTs
Measured: Up to safety follow-up visit, approximately 30 days post-treatment
Dose Escalation and Backfill parts: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of participants with SAEs in dose escalation and backfill parts graded according to NCI CTCAE v5.0
Measured: Up to safety follow-up visit, approximately 30 days post-treatment
Dose Escalation and Backfill parts: Percentage of participants with Treatment Emergent Adverse Events (TEAEs) , Grade ≥ 3 TEAE, TEAE leading to dose reduction/interruption/discontinuation
Percentage of participants who experienced any of the above TEAEs in dose escalation and backfill parts graded according to NCI CTCAE v5.0
Measured: Up to safety follow-up visit, approximately 30 days post-treatment
Dose Escalation and Backfill parts: Maximum Tolerated Dose(MTD) of DB-1324
MTD will be determined by evaluating the incidence of DLTs during the DLT assessment period.
Measured: Up to safety follow-up visit, approximately 30 days post-treatment
Secondary outcomes (13)
Dose Escalation and Backfill parts: Recommended Dose for Expansions(RDEs)
RDEs will be based on the data collected during dose escalation and backfill parts
Measured: Up to the completion of Phase 1, assessed up to 12 months
Dose Escalation, Backfill and Expansion parts: Recommended Phase 2 Dose(RP2D)
RP2D will be based on the data collected during dose escalation, backfill and expansion parts
Measured: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Objective Response Rate (ORR)
ORR will be determined by investigator per RECIST v1.1, defined as the percentage of participants who had a best response rating of CR and PR
Measured: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Duration of Response (DoR)
DoR will be determined by investigator per RECIST v1.1, defined as the time from earliest date of documented CR or PR to the date of documented disease progression or death (by any cause, in the absence of progression)
Measured: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Disease Control Rate (DCR)
DCR will be determined by investigator per RECIST v1.1, defined as the proportion of participants with best overall response of CR, PR, or SD with confirmation over a period of at least 6 weeks.
Measured: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Time to Response (TTR)
TTR will be determined by investigator per RECIST v1.1, defined as the time from the first administration to first documented CR or PR.
Measured: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Progression Free Survival (PFS)
PFS will be determined by investigator per RECIST v1.1, defined as the time from the first administration to documented disease progression or death (by any cause, in the absence of progression), whichever occurs first.
Measured: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Pharmacokinetic-AUClast
Area under the concentration-time curve from time 0 to the last of DB-1324, total anti-CDH17 antibody, and unconjugated payload.
Measured: Up to safety follow up visit, approx. 30 days post-treatment
Dose Escalation and Backfill parts: Pharmacokinetic-AUC0-τ
Area under the concentration-time curve from time 0 to time tau of DB-1324, total anti-CDH17 antibody, and unconjugated payload.
Measured: Up to safety follow up visit, approx. 30 days post-treatment
Dose Escalation and Backfill parts: Pharmacokinetic-Cmax
Maximum observed plasma concentration (Cmax) of DB-1324, total anti-CDH17 antibody, and unconjugated payload.
Measured: Up to safety follow up visit, approx. 30 days post-treatment
Dose Escalation and Backfill parts: Pharmacokinetic-Tmax
Time to Cmax of DB-1324, total anti-CDH17 antibody, and unconjugated payload.
Measured: Up to safety follow up visit, approx. 30 days post-treatment
Dose Escalation and Backfill parts: Pharmacokinetic-Cthroug
Trough concentration
Measured: Up to safety follow up visit, approx. 30 days post-treatment
Dose Escalation and Backfill parts: Anti-drug antibody (ADA) prevalence
Percentage of participants who are ADA positive at any point
Measured: Up to safety follow up visit, approx. 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start20 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by DualityBio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DualityBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Lily Hu, Study director, DualityBio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263594
- Sponsor's protocol ID
- DB-1324-101
- Status last verified
- May 2026
- First submitted
- 17 Nov 2025
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1324 in Participants With Advanced/Metastatic Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT07263594
- Acronym / sponsor ID
- DB-1324-101
- Conditions
- Gastrointestinal Cancer
- Keywords
- Gastrointestinal Tumors, DB-1324
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- DualityBio Inc.Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.
Detailed description
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2 study to explore the safety, tolerability, and efficacy of DB-1324 in participants with malignant GI tumors.
The Phase 1, which includes Dose Escalation, Backfill, and Dose Expansion to identify the MTD and determine the RDEs and RP2D.
Phase 2 will confirm the safety, tolerability, and explore efficacy in selected malignant GI tumors.
For both Phase 1 and Phase 2, participants will receive study treatment until 1) disease progression, 2) loss of clinical benefit in the opinion of the investigator, 3) unacceptable toxicity, 4) withdrawal from study treatment by participant, 5) lost to follow up, or 6) another criterion for discontinuation is met, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DB-1324 Phase 1 Dose escalation | Experimental | Drug: DB-1324Enrolled Subjects will receive a single-dose of DB-1324 at different Dose Level or different dose regimen |
| DB-1324 Phase 1 Backfill | Experimental | Drug: DB-1324Participants 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. |
| DB-1324 Phase 1 Dose Expansion | Experimental | Drug: DB-1324Two 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. |
| DB-1324 Phase 2 | Experimental | Drug: DB-1324Phase 2 will consist of one or more cohorts intended to confirm early signals of efficacy identified in Phase 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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 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.
- Uncontrolled or significant cardiovascular disease.
- Has a medical history of cerebrovascular accident including transient ischemic attack within 6 months before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DB-1324Administered I.V. | Drug | DB-1324 Phase 1 Backfill, DB-1324 Phase 1 Dose Expansion, DB-1324 Phase 1 Dose escalation, DB-1324 Phase 2 |
Primary outcome
Dose Escalation and Backfill parts: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
Time frame: Up to safety follow-up visit, approximately 30 days post-treatment
Percentage of participants in dose escalation and backfill parts with DLTs
Dose Escalation and Backfill parts: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time frame: Up to safety follow-up visit, approximately 30 days post-treatment
Percentage of participants with SAEs in dose escalation and backfill parts graded according to NCI CTCAE v5.0
Dose Escalation and Backfill parts: Percentage of participants with Treatment Emergent Adverse Events (TEAEs) , Grade ≥ 3 TEAE, TEAE leading to dose reduction/interruption/discontinuation
Time frame: Up to safety follow-up visit, approximately 30 days post-treatment
Percentage of participants who experienced any of the above TEAEs in dose escalation and backfill parts graded according to NCI CTCAE v5.0
Dose Escalation and Backfill parts: Maximum Tolerated Dose(MTD) of DB-1324
Time frame: Up to safety follow-up visit, approximately 30 days post-treatment
MTD will be determined by evaluating the incidence of DLTs during the DLT assessment period.
13 secondary outcomes
Dose Escalation and Backfill parts: Recommended Dose for Expansions(RDEs)
Time frame: Up to the completion of Phase 1, assessed up to 12 months
Dose Escalation, Backfill and Expansion parts: Recommended Phase 2 Dose(RP2D)
Time frame: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Objective Response Rate (ORR)
Time frame: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Duration of Response (DoR)
Time frame: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Disease Control Rate (DCR)
Time frame: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Time to Response (TTR)
Time frame: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Progression Free Survival (PFS)
Time frame: From the beginning of first patient in (FPI) to the end of study, approximately 36 months
Dose Escalation and Backfill parts: Pharmacokinetic-AUClast
Time frame: Up to safety follow up visit, approx. 30 days post-treatment
Dose Escalation and Backfill parts: Pharmacokinetic-AUC0-τ
Time frame: Up to safety follow up visit, approx. 30 days post-treatment
Dose Escalation and Backfill parts: Pharmacokinetic-Cmax
Time frame: Up to safety follow up visit, approx. 30 days post-treatment
Dose Escalation and Backfill parts: Pharmacokinetic-Tmax
Time frame: Up to safety follow up visit, approx. 30 days post-treatment
Dose Escalation and Backfill parts: Pharmacokinetic-Cthroug
Time frame: Up to safety follow up visit, approx. 30 days post-treatment
Dose Escalation and Backfill parts: Anti-drug antibody (ADA) prevalence
Time frame: Up to safety follow up visit, approx. 30 days post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuanyuan Sun contact
Lily Hu study director
DualityBio Inc.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DB-1324 in people with Gastrointestinal Cancer, run by DualityBio Inc. at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaochuan Wang (4123279868, zhaochuan.wang@dualitybiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation and Backfill parts: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. (time frame: Up to safety follow-up visit, approximately 30 days post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.