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Recruiting NCT07263594

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

Phase I / Phase II Interventional Gastrointestinal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DB-1324.
Who it may be relevant to
Registry conditions: Gastrointestinal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1324 in Participants With Advanced/Metastatic Gastrointestinal Tumors

Overview

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.

Interventions

  • Drug DB-1324
    Administered I.V.

Primary outcome measures

  • Dose Escalation and Backfill parts: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by 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 Serious Adverse Events (SAEs) as assessed by 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 [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 [Time frame: Up to safety follow-up visit, approximately 30 days post-treatment]
Secondary outcome measures (12)
  • Dose Escalation and Backfill parts: Recommended Dose for Expansions(RDEs) [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) [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) [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) [Time frame: 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) [Time frame: From the beginning of first patient in (FPI) to the end of study, approximately 36 months]
  • Dose Escalation and Backfill parts: Time to Response (TTR) [Time frame: From the beginning of first patient in (FPI) to the end of study, approximately 36 months]
  • Dose Escalation and Backfill parts: Progression Free Survival (PFS) [Time frame: From the beginning of first patient in (FPI) to the end of study, approximately 36 months]
  • Dose Escalation and Backfill parts: Pharmacokinetic-AUClast [Time frame: Up to safety follow up visit, approx. 30 days post-treatment]
  • Dose Escalation and Backfill parts: Pharmacokinetic-AUC0-τ [Time frame: Up to safety follow up visit, approx. 30 days post-treatment]
  • Dose Escalation and Backfill parts: Pharmacokinetic-Cmax [Time frame: Up to safety follow up visit, approx. 30 days post-treatment]
  • Dose Escalation and Backfill parts: Pharmacokinetic-Tmax [Time frame: Up to safety follow up visit, approx. 30 days post-treatment]
  • Dose Escalation and Backfill parts: Pharmacokinetic-Cthroug [Time frame: Up to safety follow up visit, approx. 30 days post-treatment]

Eligibility criteria

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.
  • Participants are willing to provide archived tumor tissue or undergo a tumor biopsy for the measurement of CDH17 levels and other biomarkers.
  • Other protocol-defined Inclusion criteria apply.

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.
  • Has clinically active brain metastases.
  • Has unresolved toxicities from previous anticancer therapy.
  • Other protocol-defined Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • USA05-0 — Port Saint Lucie
  • USA02-0 — Grand Rapids
  • USA01-0 — Huntersville
  • USA03-0 — Cincinnati
Australia · 3 centers
  • AUS02-0 — Randwick
  • AUS03-0 — South Brisbane
  • AUS01-0 — Nedlands
China · 2 centers
  • CHN01-0 — Beijing
  • CHN04-0 — Beijing

Identifiers

NCT: NCT07263594 · DB-1324-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗