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

ConditionGastrointestinal Cancer

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorDualityBio Inc.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.