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

This trial does not accept healthy volunteers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

DB-1324
Drug
Administered I.V.

Treatment groups

127 Participants

are divided into 4 treatment groups

Group A: DB-1324 Phase 1 Dose escalationExperimental treatment 1 intervention

Group B: DB-1324 Phase 1 BackfillExperimental treatment 1 intervention

Group C: DB-1324 Phase 1 Dose ExpansionExperimental treatment 1 intervention

Group D: DB-1324 Phase 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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

Time frame

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

Time frame

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.

Time frame

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

Secondary outcomes

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

RDEs will be based on the data collected during dose escalation and backfill parts

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)

RP2D will be based on the data collected during dose escalation, backfill and expansion parts

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)

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

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)

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)

Time frame

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