A Phase 1/2, Open-Label, Study of BGB-16673 in BCell Malignancies
Research type
Research Study
Full title
A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies
IRAS ID
1007339
Contact name
Kajal Patel
Contact email
Sponsor organisation
BeiGene UK Ltd
Clinicaltrials.gov Identifier
Research summary
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.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
23/EE/0127
Date of REC Opinion
25 Oct 2023
REC opinion
Further Information Favourable Opinion