First-in-Human Study of DB-1305/BNT325 for Advanced or Metastatic Solid Tumors

Sponsor: DualityBio Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05438329

Provider View

This clinical trial is testing a new drug, DB-1305/BNT325, to see if it is safe and well-tolerated in adults with advanced solid tumors that cannot be surgically removed or have spread to other parts of the body.

Patient Parameters

Program Overview

This study is designed to find out if a new drug, DB-1305/BNT325, is safe and can be tolerated by patients with advanced solid tumors. The trial is divided into two parts: the first part will determine the best dose to use, and the second part will test this dose in more patients to confirm its safety and explore its effectiveness. Participants will include adults with advanced, recurrent, or metastatic solid tumors that cannot be removed by surgery.

Description

This clinical trial is being conducted at multiple locations and involves giving multiple doses of the new drug, DB-1305/BNT325, to participants. The study is divided into two phases. In the first phase, researchers will gradually increase the dose to find the highest dose that patients can tolerate without severe side effects. This is known as the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D). In the second phase, this dose will be given to more patients to confirm its safety and to see if it helps in treating the cancer. The study is open to adults with advanced solid tumors that have returned or spread after standard treatments, or for which no standard treatment is available.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Have advanced or metastatic solid tumors that cannot be surgically removed and have returned or progressed 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 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 determined by blood tests.
  • Have stopped previous cancer treatments for a sufficient period before starting the study.
  • Be willing to provide a tumor sample for testing if possible.
  • Understand the study and agree to sign informed consent.

Exclusion Criteria

  • Have a history of heart failure or serious heart rhythm problems that require treatment.
  • Have had a heart attack or unstable chest pain within the last 6 months.
  • Have a prolonged QT interval on an ECG (QTcF greater than 470 milliseconds).
  • Have a history of lung diseases like interstitial lung disease or pneumonitis.
  • Have a significant lung illness.
  • Have an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
  • Have HIV with AIDS-defining illness, unless the CD4+ T cell count is over 350 cells/µL and there is no history of an AIDS-defining illness.

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

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