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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
337
Planned doses administered orally as a tablet daily.
Planned doses administered by intravenous infusion.
Administered in accordance with relevant local guidelines and/or prescribing information.
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
Time frame: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Time frame: Approximately 1 month
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.
Time frame: Approximately 1 month
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Approximately 6 months
Phase 1a: ORR
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
Time frame: Approximately 6 months
Phase 1a and 1b: Duration of Response (DOR)
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
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City of Hope National Medical Center
Duarte, California, United States
RECRUITINGUniversity of Southern California Norris Comprehensive
Los Angeles, California, United States
RECRUITINGYale University Yale Cancer Center
New Haven, Connecticut, United States
RECRUITINGSylvester Cancer Center, University of Miami
Miami, Florida, United States
RECRUITINGUniversity of Michigan Health System
Ann Arbor, Michigan, United States
RECRUITINGJohn Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGIcahn School of Medicine At Mount Sinai
New York, New York, United States
RECRUITINGProvidence Portland Medical Center
Portland, Oregon, United States
COMPLETEDThe University of Texas Md Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSouthside Cancer Care
Miranda, New South Wales, Australia
COMPLETED...and 18 more locations
Time frame: Approximately 9 months
Phase 1a and 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator.
Time frame: Approximately 6 months
Phase 1a and 1b: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator.
Time frame: Approximately 6 months
Phase 1b: Progression Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Time frame: Approximately 9 months
Phase 1a and 1b: Plasma concentrations of BGB-26808
Time frame: Approximately 6 months
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) for BGB-26808
Time frame: Approximately 1 month
Phase 1a and 1b: Time to maximum plasma concentration (Tmax) for BGB-26808
Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab. Single-dose and steady-state PK parameters.
Time frame: Approximately 1 month
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BGB-26808
Time frame: Approximately 1 month
Phase 1b: Number of Participants with AEs and SAEs
Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
Time frame: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months