Study on DB-1303/BNT323 for Advanced or Metastatic Solid Tumors

Sponsor: DualityBio Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05150691

Provider View

This clinical trial is testing the safety and tolerability of a new drug, DB-1303/BNT323, in patients with advanced solid tumors that have a specific protein called HER2. The study aims to find the best dose and evaluate its effects on these tumors.

Patient Parameters

Program Overview

This study is designed to test a new treatment, DB-1303/BNT323, in patients with advanced solid tumors that express the HER2 protein. The trial is divided into two parts: the first part focuses on finding the safest and most effective dose, while the second part expands the study to more patients to confirm safety and explore how well the treatment works. Participants will receive multiple doses of the drug and will be monitored for safety and any effects on their cancer.

Description

This clinical trial is being conducted at multiple centers and involves patients with advanced or metastatic solid tumors that express the HER2 protein. The study is open-label, meaning both the researchers and participants know what treatment is being given. In the first part of the study, researchers will gradually increase the dose of DB-1303/BNT323 to find the maximum dose that is safe and well-tolerated. In the second part, more patients will receive the treatment at this dose to further assess its safety and effectiveness.

Participants must have a type of cancer that is advanced, cannot be surgically removed, has returned, or has spread to other parts of the body. The cancer must also express the HER2 protein. The study will include patients who have not responded to standard treatments or for whom no standard treatment is available. Participants will need to provide a tumor sample for HER2 testing and meet other health criteria to ensure they can safely participate in the trial.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of a HER2-positive or HER2-expressing advanced solid tumor that cannot be surgically removed, has returned, or has spread.
  • Have at least one measurable tumor.
  • Be able to provide informed consent.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a heart function of 50% or higher.
  • Have adequate organ function.
  • Provide a tumor sample for HER2 testing.
  • Have a life expectancy of at least 3 months.

Additional Criteria for Part 2 Expansion Group 9:

  • Have advanced or metastatic endometrial cancer that has progressed after at least one line of systemic treatment, including platinum-based therapy and immune checkpoint inhibitors, but no more than three prior lines of therapy.

Exclusion Criteria

  • Have a history of heart failure or serious heart rhythm problems.
  • Have had a heart attack or unstable chest pain within the last 6 months.
  • Have a prolonged QT interval on an ECG.
  • Have significant lung diseases.
  • Have an uncontrolled infection requiring IV treatment.
  • Have HIV with AIDS-defining illness or active hepatitis.
  • Have active brain metastases.
  • Have unresolved side effects from previous cancer treatments.
  • Have an allergy to the study drug or its ingredients.
  • For Part 2 only: Have had multiple primary cancers within the last 3 years, except for certain non-threatening cancers.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.