Study of BGB-B2033 for Advanced Solid Tumors
This study is testing a new drug called BGB-B2033, by itself or in combination with other approved drugs, tislelizumab and bevacizumab. It's for people with advanced or metastatic (spread to other parts of the body) solid tumors, including certain types of liver cancer (hepatocellular carcinoma), stomach cancer, yolk sac tumors, or lung cancer. The main goals are to see how safe BGB-B2033 is, what side effects it might cause, and to find the best dose. Researchers will also look at how the body handles the drug and if it shows any anti-tumor activity. This study is for adults aged 18 and older. The drugs are given through an IV (into a vein).
- Study design
- This is a first-in-human study, meaning it's the first time BGB-B2033 is being tested in people. It plans to enroll 392 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for adverse events (side effects) for up to approximately 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
NCT06427941
Where you'd take part
This study runs at 51 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Anhui Provincial Hospital
Hefei, Anhui, Chinano site contact published
Recruiting
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Koreano site contact published
Recruiting
Auckland City Hospital
Auckland, New Zealandno site contact published
Recruiting
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, Japanno site contact published
Recruiting
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, Franceno site contact published
Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazilno site contact published
Recruiting
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, South Koreano site contact published
Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, Chinano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Study Director · STUDY_DIRECTOR · BeOne Medicines
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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-B2033Up 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-B2033Up 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).