RECRUITING

A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors

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Conditions

Metastatic Hepatocellular CarcinomaLocal Advanced Hepatocellular CarcinomaAlpha-fetoprotein (AFP)-Producing Gastric CancerExtragonadal Yolk Sac TumorsGlypican-3 (GPC3)-Positive Squamous Non-small Cell Lung CancerGPC-3GPC3-positive squamous non-small cell lung cancerBGB-B2033tislelizumabhepatocellular carcinomaBevacizumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a first-in-human (FIH) clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of BGB-B2033 administered as monotherapy and in combination with tislelizumab, with or without bevacizumab. The study will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors/non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC).

Official Title

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Selected Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2024-07-23
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06427941

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants must have one of the following unresectable, locally advanced, or metastatic tumor types:
  2. 1. Hepatocellular carcinoma (HCC): Histologically or cytologically confirmed HCC that is either Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not amenable to, or has progressed after, loco-regional therapy and is not eligible for a curative treatment approach.
  3. 2. Alpha-fetoprotein (AFP)-producing gastric cancer (GC): Histologically confirmed GC with AFP \> 20 ng/mL in blood or tumor tissue positive for AFP by a validated immunohistochemistry (IHC) assay based on local or central testing.
  4. 3. Germ cell tumors: Histologically confirmed germ cell tumors including extragonadal yolk sac tumors (e.g., located in the mediastinum, vagina, brain, retroperitoneum), and non-dysgerminomas for which no further curative systemic treatment options exist.
  5. 4. Glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC): Histologically confirmed GPC3-positive squamous NSCLC with prior exposure to a checkpoint inhibitor (CPI).
  6. 2. At least one evaluable lesion for dose escalation, and
  7. 3. At least one measurable lesion for safety expansion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  8. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  9. 5. Adequate organ function as defined in the protocol.
  10. 6. Provision of tumor tissue samples is required for specified parts of the study.
  1. 1. Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137).
  2. 2. Active leptomeningeal disease or uncontrolled/untreated brain metastases.
  3. 3. Active autoimmune disease or a history of autoimmune disease with potential for relapse.
  4. 4. Any malignancy diagnosed ≤ 2 years before the first dose of study drug(s), except: The cancer type under investigation in this study, or Locally recurring malignancies previously treated with curative intent.
  5. 5. Requirement for systemic corticosteroids (\> 10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to the first dose of study drug(s).
  6. 6. Certain comorbidities involving the lungs, heart, bleeding conditions, or active infections, as defined in the protocol.

Contacts and Locations

Study Contact

Study Director
CONTACT
1.877.828.5568
clinicaltrials@beonemed.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeOne Medicines

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800
United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, 15232-1309
United States
Scri Oncology Partners
Nashville, Tennessee, 37203-1503
United States

Collaborators and Investigators

Sponsor: BeOne Medicines

  • Study Director, STUDY_DIRECTOR, BeOne Medicines

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-23
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-07-23
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • GPC-3
  • GPC3-positive squamous non-small cell lung cancer
  • BGB-B2033
  • tislelizumab
  • hepatocellular carcinoma
  • alpha-fetoprotein (AFP)-producing gastric cancer
  • extragonadal yolk sac tumors
  • Bevacizumab

Additional Relevant MeSH Terms

  • Metastatic Hepatocellular Carcinoma
  • Local Advanced Hepatocellular Carcinoma
  • Alpha-fetoprotein (AFP)-Producing Gastric Cancer
  • Extragonadal Yolk Sac Tumors
  • Glypican-3 (GPC3)-Positive Squamous Non-small Cell Lung Cancer