A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors

NCT ID: NCT07263594

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

Brief Summary

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.

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DB-1324 Phase 1 Dose escalation

Enrolled Subjects will receive a single-dose of DB-1324 at different Dose Level or different dose regimen

Group Type: EXPERIMENTAL

DB-1324

Intervention Type: DRUG

Administered I.V.

DB-1324 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 the safety, efficacy, PK, and pharmacodynamics of DB-1324.

Group Type: EXPERIMENTAL

DB-1324

Intervention Type: DRUG

Administered I.V.

DB-1324 Phase 1 Dose Expansion

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 Type: EXPERIMENTAL

DB-1324

Intervention Type: DRUG

Administered I.V.

DB-1324 Phase 2

Phase 2 will consist of one or more cohorts intended to confirm early signals of efficacy identified in Phase 1.

Group Type: EXPERIMENTAL

DB-1324

Intervention Type: DRUG

Administered I.V.

Interventions

DB-1324

Administered I.V.

Intervention Type: DRUG

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 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

DualityBio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lily Hu

Role: STUDY_DIRECTOR

DualityBio Inc.

Locations

USA02-0

Grand Rapids, Michigan, United States

USA01-0

Huntersville, North Carolina, United States

USA03-0

Cincinnati, Ohio, United States

AUS02-0

Randwick, New South Wales, Australia

AUS03-0

South Brisbane, Queensland, Australia

AUS01-0

Nedlands, Western Australia, Australia

Countries

United States; Australia

Central Contacts

Yuanyuan Sun

Role: CONTACT

Yuanyuan.Sun@dualitybiologics.com

01067228087

Other Identifiers

DB-1324-101

Identifier Type: -

Identifier Source: org_study_id