Phase 1 Study to Find Safe and Effective Doses of BGB-26808 Alone or With Tislelizumab for Treating Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating BGB-26808, alone or combined with tislelizumab, in people with advanced solid tumors that are metastatic or cannot be removed by surgery. This open-label, multicenter, nonrandomized Phase 1 study aims to find the recommended doses of BGB-26808 and assess its safety, tolerability, and early antitumor activity. The study is sponsored by BeOne Medicines, previously known as BeiGene. Participants will receive increasing doses of BGB-26808 either by itself or combined with tislelizumab and chemotherapy, depending on the study phase. BGB-26808 is given daily as an oral tablet, while tislelizumab is administered by intravenous infusion. The study includes a dose escalation phase Phase 1a and a dose expansion phase Phase 1b to evaluate appropriate dosing and response. During the study, participants will be monitored for adverse events and serious adverse events from the first dose until 90 days after the last dose or start of new treatment, for up to about 12 months. Researchers will also measure tumor response rates, duration of response, disease control, clinical benefit, and pharmacokinetic properties like drug concentration in the blood. Study visits will include tumor assessments, blood tests, and safety evaluations over several months.

A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors