Study on the Safety and Effectiveness of BGB-16673 with Other Treatments for Relapsed or Refractory B-Cell Blood Cancers

Sponsor: BeiGene

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06634589

Provider View

This clinical trial is testing a new drug, BGB-16673, combined with other medications to see if it is safe and effective for patients with B-cell blood cancers that have returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to evaluate the safety and initial effectiveness of a new cancer drug, BGB-16673, when used with other treatments in patients with B-cell blood cancers that have come back or are resistant to treatment. The study is organized into different parts, each testing BGB-16673 with a different drug combination. Currently, there are four parts, and more may be added as new drug combinations are identified.

Description

This study is exploring how safe and effective a new drug, BGB-16673, is when used with other medications for treating B-cell blood cancers that have returned or are not responding to treatment. The study is divided into four parts, each testing BGB-16673 with a different drug: sonrotoclax, zanubrutinib, mosunetuzumab, and glofitamab. Each part of the study will help determine how well these combinations work and how safe they are for patients.

Eligibility Criteria

Inclusion Criteria

  • Must agree to participate and sign a consent form.
  • Have a confirmed diagnosis of relapsed or refractory B-cell blood cancer.
  • Have a measurable disease as defined by the study.
  • Be in stable health with a performance status score between 0 and 2.
  • Have good organ function.
  • Women who can become pregnant must use effective birth control and not donate eggs during the study and for a specified time after the last dose of the study drugs.
  • Men must use effective birth control and not donate sperm during the study and for a specified time after the last dose of the study drugs.
  • For parts 1, 3, and 4: Have good kidney function with a filtration rate of at least 50 mL/min.
  • For part 2: Must not have been treated with a BTK inhibitor before, or have stopped using one for reasons other than cancer progression, and have good kidney function with a filtration rate of at least 30 mL/min.

Exclusion Criteria

  • Have not been treated for B-cell blood cancer before.
  • Cannot follow the study requirements.
  • Have active brain or spinal cord cancer that is not controlled or treated.
  • Have had any other cancer within 2 years before starting the study, except for the specific cancer being studied or any local cancer that has been treated and cured.
  • Have had a stem cell transplant or CAR-T cell therapy within 3 months before the study.
  • For parts 1 and 2: Have had a stem cell transplant with active graft-versus-host disease or need immunosuppressive drugs for it, or have used certain drugs within 4 weeks before the study.
  • Have severe allergies to the study drugs or their ingredients.
  • For part 1: Have been treated with a Bcl-2 inhibitor before, unless the cancer returned 24 months after finishing the treatment.
  • For part 2: Have stopped taking zanubrutinib before due to intolerance.
  • For parts 3 and 4: Have been treated with a CD20 x CD3 T-cell engager antibody before, or have had a stem cell transplant.

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