Study on BGB-B2033 Alone or with Tislelizumab and Bevacizumab for Advanced or Metastatic Solid Tumors

Sponsor: BeOne Medicines

Sponsor score: 0

ClinicalTrials ID:NCT06427941

This clinical trial is testing the safety and effects of a new drug, BGB-B2033, alone or combined with other drugs, in adults with advanced or metastatic liver cancer, certain gastric cancers, and other specific tumor types.

Patient Parameters

Program Overview

The purpose of this study is to see if the new drug BGB-B2033 is safe and how it affects the body when given alone or with other drugs like tislelizumab and bevacizumab. The study focuses on adults with advanced or metastatic liver cancer, certain gastric cancers, and other specific types of tumors. Researchers want to find out if BGB-B2033 can help reduce tumors and determine the best dose for future studies. Participants will receive the drug through an IV, either alone or with other medications, and will have regular check-ups to monitor their health and the drug's effects.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic cancer that cannot be removed by surgery, including:
    • Liver cancer (HCC) that has progressed after certain treatments.
    • Gastric cancer that produces a protein called AFP.
    • Certain germ cell tumors with no other treatment options.
    • Lung cancer (NSCLC) that is positive for a protein called GPC3 and has been treated with a checkpoint inhibitor.
  • Have at least one tumor that can be measured by scans.
  • 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 adequate organ function as determined by specific tests.
  • Provide a tumor tissue sample for the study.

Exclusion Criteria

  • Have had previous treatments targeting GPC3 or a specific immune receptor (4-1BB).
  • Have active cancer in the brain or spinal fluid that is not controlled.
  • Have an active autoimmune disease or a history of one that could relapse.
  • Have had another type of cancer diagnosed within the last two years, except for the cancer being studied or certain treated local cancers.
  • Need to take high doses of steroids or other immune-suppressing drugs.
  • Have certain lung, heart, bleeding, or infection-related health issues.

Locations

FACILITYZIPCITYSTATE
University of Alabama At Birmingham Hospital35294-0004BirminghamAlabama
City of Hope Phoenix Cancer Center85338GoodyearArizona
City of Hope National Medical Center91010-3012DuarteCalifornia
City of Hope Chicago Cancer Center60099ZionIllinois
Memorial Sloan Kettering Cancer Center Mskcc10065-6800New YorkNew York
Upmc Hillman Cancer Center(Univ of Pittsburgh)15232-1309PittsburghPennsylvania
Scri Oncology Partners37203-1503NashvilleTennessee
The University of Texas Md Anderson Cancer Center77030-4009HoustonTexas

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