Not Yet RecruitingPhase 1/2

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

United States, Australia127 participantsStarted 2025-12

Plain-language summary

This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Dose Escalation and Backfill parts: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.

Timeframe: 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.

Timeframe: 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

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

Dose Escalation and Backfill parts: Maximum Tolerated Dose(MTD) of DB-1324

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

Trial details

NCT IDNCT07263594

SponsorDualityBio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Yuanyuan Sun

01067228087 Yuanyuan.Sun@dualitybiologics.com

View on ClinicalTrials.gov More Gastrointestinal Cancer trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.