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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.

Eligibility criteria

Qualifiers

Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

Phase 1a: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have previously received standard systemic therapy, or for whom treatment is not available or not tolerated, or for whom treatment is determined not appropriate based on investigator's judgment and who have not received prior therapy targeting hematopoietic progenitor kinase 1 (HPK1).

Phase 1b: Participants with histologically confirmed locally advanced unresectable or metastatic tumor types and who have not had prior systemic treatment. Participants who received prior systemic therapy in a neo-adjuvant or adjuvant setting with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of systemic therapy prior to the first dose of study treatments.

Disqualifiers

Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.

Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.

Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).

Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

Trial design

Treatments tested in this trial

  • BGB-26808
  • Tislelizumab
  • Chemotherapy

Treatment groups

217 Participants
are divided into 2 treatment groups

Locations

28
Australia
Southside Cancer CareNSW 2228, MirandaNew South Wales, Australia
Macquarie UniversityNSW 2109, North RydeNew South Wales, Australia
Icon Cancer Centre Kurralta ParkSA 5037, Kurralta ParkSouth Australia, Australia
Linear Clinical ResearchWA 6009, NedlandsWestern Australia, Australia

Sponsors and collaborators

BeOne Medicines

Lead sponsor