A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
630 (estimated)
Sponsor
BeOne Medicines · Industry
Who this trial is looking for
This trial is looking for people with certain advanced cancers. Participants will receive a new treatment either alone or with other medications to see how well it works and what side effects it may have.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with advanced hepatocellular carcinoma.
I have been diagnosed with AFP-producing gastric cancer.
I have a type of germ cell tumor with no further treatment options.
I have been diagnosed with GPC3-positive squamous non-small cell lung cancer.
I have at least one tumor that can be measured.
I have good overall health based on a performance status scale.
I can provide tumor tissue samples.
You may not be able to join if
I have received treatment targeting GPC3 or CD137 before.
I have uncontrolled brain metastases or active leptomeningeal disease.
I have an active autoimmune disease.
I was diagnosed with another cancer in the last 2 years.
I need high doses of steroids or other immunosuppressive therapies.
I have serious lung or heart conditions, bleeding problems, or active infections.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BGB-B2033 alone or in combination with tislelizumab, with or without bevacizumab, in adults with advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors, non-dysgermi…
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BGB-B2033 alone or in combination with tislelizumab, with or without bevacizumab, in adults with 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). The study will also determine the recommended Phase 2 dose (RP2D) of BGB-B2033 when given alone or in combination with tislelizumab and bevacizumab. The main questions it aims to answer are:
* Is BGB-B2033 safe and tolerable when given alone or in combination with tislelizumab, with or without bevacizumab?
* How does the body process BGB-B2033, and what are its effects on the body?
* Does BGB-B2033 show preliminary antitumor activity in participants with advanced or metastatic cancer?
Researchers will evaluate different doses and treatment combinations to determine the safest and most appropriate dose of BGB-B2033 for further study.
Participants will:
* Receive BGB-B2033 by intravenous infusion, either alone or in combination with tislelizumab, with or without bevacizumab.
* Have regular assessments to monitor safety, side effects, how their body processes and responds to BGB-B2033, and whether their cancer responds to treatment.
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
1. Participants must have one of the following unresectable, locally advanced, or metastatic tumor types:
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…
Key Inclusion Criteria:
1. Participants must have one of the following unresectable, locally advanced, or metastatic tumor types:
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.
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.
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.
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).
2. At least one evaluable lesion for dose escalation, and at least one measurable lesion for safety expansion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
4. Adequate organ function as defined in the protocol.
5. Provision of tumor tissue samples is required for specified parts of the study.
Key Exclusion Criteria:
1. Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137).
2. Active leptomeningeal disease or uncontrolled/untreated brain metastases.
3. Active autoimmune disease or a history of autoimmune disease with potential for relapse.
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. 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. Certain comorbidities involving the lungs, heart, bleeding conditions, or active infections, as defined in the protocol.
Note: Additional protocol-defined inclusion and exclusion criteria may apply.
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