This is a First in Human (FIH) Phase 1, multicenter, open label, dose escalation and dose
expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,
and preliminary antitumor activity of BGB-30813 as monotherapy or in combination with
tislelizumab in participants with advanced or metastatic solid tumors. The study will be
conducted in 2 parts: Phase 1a dose escalation and Phase 1b dose expansion.
Additional locations may be listed on ClinicalTrials.gov for NCT05904496.
See trial information on ClinicalTrials.gov for a list of participating sites.
This study will test whether taking BGB-30813 alone or with tislelizumab can help treat
patients with cancer that has spread throughout the body or is locally advanced. The two
main goals of the study are to ensure that the treatments are safe by monitoring side
effects and to determine the number of participants who respond well to treatment either
partially or completely. The combination of BGB-30813 with other drugs that target immune
checkpoints may work together to stop or prevent cancer activity.
Approximately 200 participants will participate. In the first part of the study,
participants will be given different doses of BGB-30813 either alone or with tislelizumab
to find the dose that is best tolerated. BGB-30813 will be given orally and tislelizumab
will be given through a vein. In the second part of the study, the selected dose of
BGB-30813, either alone or with tislelizumab, will be given to a larger number of
participants from different parts of the world to see if the treatments can improve the
signs and symptoms of their cancer. Treatments will continue until participants are no
longer considered to be receiving benefits, have unacceptable side effects, or withdraw
consent.
Lead OrganizationBeiGene Company Limited