A Phase 1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Assess Safety, Tolerability and Antitumor Activities of the Combination of BGB-3111 With BGB-A317 in Subjects With B-Cell Lymphoid Malignancies
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 75
- Locations
- 10
- Primary Endpoint
- Dose Escalation: RP2D of Tislelizumab
Study Overview
Brief Summary
This study is evaluating the safety and preliminary efficacy of BGB-3111 in combination with BGB-A317 in participants with B-cell lymphoid malignancies.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Zanubrutinib abd Tislelizumab
Based on results of the dose escalation cohorts and the identified recommended Phase 2 dose, all patients will receive zanubrutinib at 160 mg orally twice daily in combination with intravenous infusion of tislelizumab 200mg given every 21 days, to be continued until disease progression, unacceptable toxicity, treatment consent withdrawal, or study termination
Intervention: Zanubrutinib (Drug)
Zanubrutinib abd Tislelizumab
Based on results of the dose escalation cohorts and the identified recommended Phase 2 dose, all patients will receive zanubrutinib at 160 mg orally twice daily in combination with intravenous infusion of tislelizumab 200mg given every 21 days, to be continued until disease progression, unacceptable toxicity, treatment consent withdrawal, or study termination
Intervention: Tislelizumab (Drug)
Outcomes
Primary Outcomes
Dose Escalation: RP2D of Tislelizumab
Time Frame: From the date of first dose of study drugs until final R2PD was decided (Approximately 1 year and 10 months)
The RP2D of tislelizumab in combination with zanubrutinib will be selected by taking into account the safety, tolerability, and pharmacokinetic (PK) profile.
Dose Escalation: Maximum Tolerated Dose (MTD) of Tislelizumab
Time Frame: From the date of first dose of study drugs until RP2D was determined (Approximately 1 year and 10 months)
The MTD of tislelizumab is considered the dose level below that at which at least 2 participants (or at least 33%) experience a dose-limiting toxicity (DLT).
Secondary Outcomes
- Number of Participants With Anti-Drug Antibodies (ADAs) to Tislelizumab(From the day of first dose of study drug until end of study (up to 4 years and 6 months))
- Number of Participants With TEAEs and SAEs(From the day of first dose of study drug until end of study (up to 4 years and 6 months))
- Overall Response Rate(Up to 4 years and 6 months)
- Progression Free Survival (PFS)(Up to 4 years and 6 months)
- Duration of Response (DOR)(Up to 4 years and 6 months)