BGB-58067-101 A Phase 1a/1b Study in Advanced Solid Tumours
Research type
Research Study
Full title
A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination with Anticancer Agents in Patients With Advanced Solid Tumors
IRAS ID
1013682
Contact name
Shehri Lafon
Contact email
Sponsor organisation
BeOne Medicines Ltd
Clinicaltrials.gov Identifier
Research summary
The main purpose of this study is to test the safety and tolerability of study medication BGB-58067 when given on its own, or when given in combination with other anti-cancer medications including a medication called tislelizumab and standard-of-care chemotherapies in participants with advanced solid tumours possessing the MTAP gene deletion/deficiency. MTAP gene deletion/deficiency means that the MTAP gene within the cancer cells is missing. The study will therefore need to firstly check if participants’ tumours have the MTAP gene deletion/deficiency before they can take part in the study. The study will also find the safest and most appropriate dosage(s) as well as looking at how the body processes the study medication (either alone or as part of a combination) and to see whether there is evidence of this working to treat this type of cancer.
This study has two phases: Phase 1a and phase 1b. The UK will only take part in Phase 1b.
Participants will receive treatment according to Phase 1b Part A, C or D which is based on their cancer type and prior treatment history (please note that the UK will not take part in Phase 1b Part B). The study is open label meaning both the participant and the study doctor will know what study treatment participants are taking.
Up to 820 participant will take part in the whole study globally (Phase 1a and 1b). For phase 1b up to 510 participants will take part globally. The target recruitment for the UK is approximately 5 participants and the target number of UK sites is up to 4. We currently have 1 selected, however, we plan to continue site identification activities while the initial study application is being reviewed. We have also engaged the NIHR CRN to help us identify further sites within the UK.
Overall, participation in the study is estimated to be up to 24 months and will involve up to 35 visits approximately. However, the expected number of visits varies depending on whether participants take part in Part A, C or D.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
26/EE/0068
Date of REC Opinion
23 Apr 2026
REC opinion
Further Information Unfavourable Opinion