BGB-16673-101 - A Phase 1, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies.
Recipient organisationNIHR Nottingham Clinical Research Facility
NIHR supportRecorded as supported by this research centre
PeriodJan 2025 — Mar 2026
In plain English
AI plain-English summary
A new cancer drug called BGB-16673 is being tested for the first time in humans, with around 240 participants worldwide receiving gradually increasing doses to find a safe and effective level. This matters because many B-cell malignancies—cancers that affect white blood cells, such as certain lymphomas and leukaemias—eventually stop responding to existing treatments. BGB-16673 works differently: instead of simply blocking a cancer-driving protein called Bruton tyrosine kinase (BTK), it tags the protein for destruction inside the cell. This approach may overcome resistance that develops when cancer cells mutate around standard BTK inhibitors. If the trial succeeds, BGB-16673 could become a new treatment option for patients whose cancers have relapsed or become resistant to current therapies. The study is funded by BeiGene, Ltd and is divided into two parts: dose escalation to establish safety, followed by expansion in specific cancer types. No immediate daily-life impact is expected—this is early-stage clinical testing that will determine whether the drug is safe enough to move into larger trials.
View original technical description
This is an open-label study, which means that the participants, study doctor, and the research team know that the participants are receiving study medication and know participants are receiving which doses of study medication. This is a multicentre and Phase 1 (first-in-human) study of BGB 16673.This study will look at the safety and tolerability of an investigational anticancer medication currently known as BGB-16673. This study aims to determine BGB-16673 dose that can safely be used, what side effects may be experienced when taking this medication, how body processes this, and if this is effective against cancer. The study has 2 parts. Part 1 determines the safety, tolerability of BGB-16673 and maximum dose to be recommended for part 2. Part 2 evaluate the safety and tolerability of BGB-16673 at the recommended dose for the selected types of cancer.Part 1 consists of 2 parts, Part 1A and Part 1B. Part 1A will be the dose escalation portion, in which first few participants who enter the study will be given the smallest dose of study drug. If this dose is well-tolerated, the next group of participants will receive a slightly higher dose. The study drug dose will be increased gradually until the highest planned dose is tested. The increase in dose will not happen if there is any safety concern related to BGB-16673 at the doses tested. The dose may also be decreased if it appears higher doses will not be well tolerated. Alternate dose levels may also be tested if there is any safety or tolerability concerns at the planned dose levels. Part 1B will be a safety expansion. The aim of Part 1B is to collect more information to choose the recommended dose of study medication for part 2. Part 2 evaluate the study medication with selected types of cancer at a dose that was deemed to be well tolerated in part 1. The research study is conducted and funded by BeiGene, Ltd and approximately, 240 participants will participate in this global study.
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