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

NCT07263594 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: DB-1324-101
• Study Type: interventional
• Target: 127
• Locations: 2 countries
• Sites: 6

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.

Conditions

Gastrointestinal Cancer

Keywords

Gastrointestinal Tumors, DB-1324

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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.

  Up to safety follow-up visit, approximately 30 days post-treatment

Secondary Outcomes (13)

• Dose Escalation and Backfill parts: Recommended Dose for Expansions(RDEs)

  Up to the completion of Phase 1, assessed up to 12 months

• Dose Escalation, Backfill and Expansion parts: Recommended Phase 2 Dose(RP2D)

  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)

  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)

  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)

  From the beginning of first patient in (FPI) to the end of study, approximately 36 months

Study Arms (4)

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

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.

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.

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.

Drug: DB-1324

Interventions

DB-1324 DRUG

Administered I.V.

DB-1324 Phase 1 Backfill; DB-1324 Phase 1 Dose Expansion; DB-1324 Phase 1 Dose escalation; DB-1324 Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• DualityBio Inc.: lead
• GlaxoSmithKline: collaborator

Study Sites (6)

USA02-0

Grand Rapids, Michigan, 49546, United States

Location

USA01-0

Huntersville, North Carolina, 28078, United States

Location

USA03-0

Cincinnati, Ohio, 45219, United States

Location

AUS02-0

Randwick, New South Wales, 2031, Australia

Location

AUS03-0

South Brisbane, Queensland, 4101, Australia

Location

AUS01-0

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Lily Hu

  DualityBio Inc.

  STUDY DIRECTOR

Central Study Contacts

Yuanyuan Sun

CONTACT

01067228087; Yuanyuan.Sun@dualitybiologics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

AU (3); US (3)