A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-26808 Alone or in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
BeOne Medicines
Summary
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.
Description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 3. 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 pr…
Interventions
- DrugBGB-26808
Planned doses administered orally as a tablet daily.
- DrugTislelizumab
Planned doses administered by intravenous infusion.
- DrugChemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Locations (27)
- City of Hope National Medical CenterDuarte, California
- University of Southern California Norris ComprehensiveLos Angeles, California
- Yale University, Yale Cancer CenterNew Haven, Connecticut
- Sylvester Cancer Center, University of MiamiMiami, Florida
- John Theurer Cancer Center Hackensack University Medical CenterHackensack, New Jersey
- Icahn School of Medicine At Mount SinaiNew York, New York