Informations générales (source: ClinicalTrials.gov)
A Phase 1/2 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
Interventional
Phase 1/Phase 2
BeOne Medicines (Voir sur ClinicalTrials)
juillet 2024
octobre 2028
09 septembre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Christophe MASSARD | 26/08/2026 14:25:03 | Contacter | ||
Critères
Tous
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.