A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
BGB-26808: Planned doses administered orally as a tablet daily.
Tislelizumab: Planned doses administered by intravenous infusion.
Chemotherapy: Administered in accordance with relevant local guidelines and/or prescribing information.
Study 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.
Eligibility
Primary outcome measure(s)
- Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — 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
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. - Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808 — Approximately 1 month
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. - Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808 — Approximately 1 month
RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD. - Phase 1b: Overall Response Rate (ORR) — Approximately 6 months
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.
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | Recruiting |
| University of Southern California Norris Comprehensive | Los Angeles | California | Recruiting |
| Yale University Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Sylvester Cancer Center, University of Miami | Miami | Florida | Recruiting |
| University of Michigan Health System | Ann Arbor | Michigan | Recruiting |
| John Theurer Cancer Center Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Icahn School of Medicine At Mount Sinai | New York | New York | Recruiting |
| Providence Portland Medical Center | Portland | Oregon | Completed |
| The University of Texas Md Anderson Cancer Center | Houston | Texas | Recruiting |
| Southside Cancer Care | Miranda | New South Wales | Completed |
| Macquarie University | North Ryde | New South Wales | Active Not Recruiting |
| Icon Cancer Centre Kurralta Park | Kurralta Park | South Australia | Active Not Recruiting |
| Linear Clinical Research | Nedlands | Western Australia | Completed |
| The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch | Hefei | Anhui | Recruiting |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | Recruiting |
| Hubei Cancer Hospital | Wuhan | Hubei | Recruiting |
| Tongji Hospital,Tongji Medical College of Hustsino French New City Branch | Wuhan | Hubei | Recruiting |
| The First Hospital of China Medical University Hunnan Branch | Shenyang | Liaoning | Recruiting |
| Jining No1 Peoples Hospital West Branch | Jining | Shandong | Recruiting |
| Yantai Yuhuangding Hospital | Yantai | Shandong | Recruiting |
| Shanghai East Hospital Branch Hospital | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | Completed |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital | Chengdu | Sichuan | Recruiting |
| Hangzhou First Peoples Hospital | Hangzhou | Zhejiang | Recruiting |
| Taizhou Hospital of Zhejiang Province (East) | Taizhou | Zhejiang | Completed |
| Auckland City Hospital | Auckland | New Zealand | Recruiting |
| Harbour Cancer and Wellness | Auckland | New Zealand | Recruiting |
| Health New Zealand Te Whatu Ora Lakes Rotorua Hospital | Rotorua | New Zealand | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05981703 on ClinicalTrials.gov ↗ ← All trials in China