Study on DB-1310 for Advanced or Metastatic Solid Tumors

Sponsor: DualityBio Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05785741

Provider View

This clinical trial is testing a new drug, DB-1310, to see if it is safe and well-tolerated in adults with advanced solid tumors. The study will also explore the best dose for future research.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and tolerability of a new drug called DB-1310 in adults with advanced solid tumors. The trial is divided into two phases: Phase 1 will determine the safest dose of DB-1310, both alone and in combination with other drugs like trastuzumab and Osimertinib. Phase 2a will expand on this to confirm safety and explore how effective the drug is in treating certain types of cancer.

Description

This study is being conducted at multiple centers and involves giving multiple doses of DB-1310 to participants. In Phase 1, researchers will use a standard method to find the maximum safe dose of DB-1310 when used alone and in combination with other cancer drugs. In Phase 2a, the study will expand to include more participants to confirm the safety and explore the effectiveness of DB-1310 in treating specific types of advanced solid tumors. Participants will receive DB-1310 either by itself or in combination with trastuzumab or Osimertinib, depending on their specific cancer type.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Have cancer that has returned or progressed after standard treatments, or cannot tolerate standard treatments, or have no standard treatment options 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.
  • 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.
  • Understand the study and agree to sign informed consent.
  • Agree to use effective birth control during the study and for a specified time after the last dose.
  • Men must not donate sperm during the study and for 4 months after the last dose.
  • Women must not donate eggs during the study and for 7 months after the last dose.

Exclusion Criteria

  • Have had previous treatment targeting HER3.
  • Have had certain types of cancer treatments involving topoisomerase I inhibitors.
  • Have a history of serious heart problems or recent heart attack.
  • Have abnormal heart rhythms or prolonged QT interval on an ECG.
  • Cannot stop taking medications that affect heart rhythm.
  • Have a history of lung diseases like pneumonia or fibrosis.
  • Have an uncontrolled infection requiring IV antibiotics.
  • Have significant eye disease affecting the cornea.
  • Have HIV infection.
  • Have active hepatitis, unless under specific conditions.
  • Are pregnant or breastfeeding.
  • Have untreated or symptomatic brain metastases, unless stable after treatment and on low-dose steroids.

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