Study on DB-1324 for Advanced or Metastatic Gastrointestinal Tumors

Sponsor: DualityBio Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07263594

Provider View

This clinical trial is testing a new drug, DB-1324, to see if it is safe and effective for treating advanced or metastatic gastrointestinal tumors. The study will determine the best dose and evaluate how well the drug works against these types of cancer.

Patient Parameters

Program Overview

This study is the first to test DB-1324, a new drug for treating advanced or metastatic gastrointestinal (GI) tumors. The trial aims to find out if the drug is safe, how it behaves in the body, and its potential to fight cancer. The study is divided into two phases: Phase 1 will focus on finding the best dose and understanding the drug's safety, while Phase 2 will further explore its effectiveness in treating specific GI cancers. Participants will continue receiving the treatment until their cancer progresses, they experience unacceptable side effects, or they choose to stop.

Description

This clinical trial is being conducted at multiple centers and involves giving multiple doses of DB-1324 to participants with advanced or metastatic gastrointestinal tumors. The study is divided into two phases:

  • Phase 1: This phase includes several parts to determine the maximum tolerated dose (MTD) and the recommended dose for future studies. It will also assess the safety and how the drug works in the body.

  • Phase 2: This phase will confirm the safety and tolerability of DB-1324 and explore its effectiveness in treating selected GI tumors.

Participants will receive the study treatment until their cancer progresses, they no longer benefit from the treatment, they experience severe side effects, they decide to stop, or they are lost to follow-up. The study will end for a participant if any of these conditions occur first.

Eligibility Criteria

Inclusion Criteria

  • Have an advanced or metastatic gastrointestinal tumor that cannot be surgically removed.
  • Have tried standard treatments that did not work or were not tolerated, or there are no standard treatments available.
  • Have at least one tumor that can be measured by scans.
  • Have a life expectancy of at least 3 months.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a heart function of at least 50% as measured by specific tests.
  • Have adequate organ function as shown by recent blood tests.
  • Have stopped previous cancer treatments for a sufficient time before starting the study.
  • Be willing to provide a tumor sample for testing.
  • Meet other specific criteria as defined by the study protocol.

Exclusion Criteria

  • Have previously received treatment targeting CDH17 or with a specific type of drug called ADC with topoisomerase I inhibitor.
  • Have chronic inflammation of the intestines or significant bleeding in the digestive tract.
  • Have serious heart disease that is not controlled.
  • Have had a stroke or mini-stroke in the past 6 months.
  • Have a history of lung inflammation that required steroids or current lung issues that cannot be ruled out.
  • Have a serious lung illness.
  • Have an uncontrolled infection requiring IV antibiotics or antivirals.
  • Have active cancer spread to the brain.
  • Have unresolved side effects from previous cancer treatments.
  • Meet other specific criteria as defined by the study protocol.

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