First-in-Human Study of DB-1419 for Advanced or Metastatic Solid Tumors

Sponsor: DualityBio Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06554795

Provider View

This clinical trial is testing a new drug, DB-1419, to see if it is safe and effective for adults with advanced or metastatic solid tumors that have not responded to standard treatments.

Patient Parameters

Program Overview

This study is the first to test a new drug called DB-1419 in humans. It aims to find out if the drug is safe and how it behaves in the body, as well as its potential to fight cancer in people with advanced or metastatic solid tumors. Participants will receive the drug and be monitored for any side effects and changes in their cancer.

Description

This clinical trial is designed to evaluate the safety, tolerability, and initial effectiveness of a new drug, DB-1419, in adults with advanced or metastatic solid tumors. The study will take place at multiple centers and is open-label, meaning both the researchers and participants know what treatment is being given. Participants will receive DB-1419 and undergo various tests to monitor their health and the drug's effects on their cancer. The study will also look at how the drug is processed in the body and its preliminary ability to reduce tumors.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Have a confirmed diagnosis of advanced or metastatic solid tumor that cannot be removed by surgery and has worsened after standard treatments, or for which no standard treatment is 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 a performance status score 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 determined by blood tests.
  • Have stopped previous cancer treatments for a sufficient period before starting the study drug.
  • Be willing to provide a tumor sample for research purposes, if possible.
  • Understand the study and agree to sign informed consent.

Exclusion Criteria

  • Have previously received treatment targeting B7-H3.
  • Have a history of serious heart problems, such as heart failure or recent heart attack.
  • Have a prolonged QT interval on an ECG, which is a measure of heart rhythm.
  • Have a history of lung diseases like pneumonia or pulmonary fibrosis.
  • Have severe lung conditions or require supplemental oxygen.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have an uncontrolled infection needing intravenous antibiotics.
  • Have known HIV infection.
  • Have untreated or symptomatic brain metastases requiring steroids or anticonvulsants.

Note: Other criteria may apply as defined by the study protocol.

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