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

Condition(s) studied

Investigational drug(s) / intervention(s)

BGB-B2033: Administered by intravenous infusion

Tislelizumab: Administered by intravenous infusion

Bevacizumab: Administered by intravenous infusion

Study summary

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.

Eligibility

Primary outcome measure(s)

• Part A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to approximately 2 years
  Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0/American Society for Transplantation and Cellular Therapy \[ASTCT\] for cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\]), timing, seriousness, and relationship to study therapy; assessment of adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
• Part A and B: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033 — Up to approximately 2 years
  The MTD or MAD is defined as the highest dose that is tolerable or the highest dose administered, respectively.
• Part A and B: Recommended Phase 2 dose (RP2D) of BGB-B2033 — Up to approximately 2 years
  The RP2D(s) will be determined based on a biologically effective dose by taking the totality of available preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration
• Parts C, D, and E: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC) — Up to approximately 2 years
  ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

Trial sites (51)

+ 11 more sites — see the full list on the official registry below.

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