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Zanubrutinib (BGB-3111) in Combination With Tislelizumab (BGB-A317) in Participants With B-cell Malignancies

Phase 1
Completed
Conditions
Lymphoma
Leukemia
Interventions
Registration Number
NCT02795182
Lead Sponsor
BeiGene
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
75
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Zanubrutinib abd TislelizumabZanubrutinibBased 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
Zanubrutinib abd TislelizumabTislelizumabBased 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
Primary Outcome Measures
NameTimeMethod
Dose Escalation: RP2D of TislelizumabFrom 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 TislelizumabFrom 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 Outcome Measures
NameTimeMethod
Number of Participants With Anti-Drug Antibodies (ADAs) to TislelizumabFrom 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 SAEsFrom the day of first dose of study drug until end of study (up to 4 years and 6 months)

A treatment-emergent adverse event (TEAE) was defined as an AE that had an onset date during the treatment emergent period, defined as from the first dose date of zanubrutinib or tislelizumab (whichever is earlier) through 30 days after the last dose (permanent discontinuation of study drug) of zanubrutinib or 90 days after the last dose of tislelizumab, whichever is later, or prior to initiation of new anti-cancer therapy. Treatment-related serious adverse events (SAEs) and any worsening of a TEAE by PT post treatment-emergent period were also counted as TEAEs.

Overall Response RateUp to 4 years and 6 months

ORR, is defined as the percentage of participants who had complete response (CR) or partial response (PR) by standard disease-specific response criteria. for WM participants ORR includes minor response (MR) and very good partial response (VGPR).

Progression Free Survival (PFS)Up to 4 years and 6 months

PFS, is defined as the time from the first dose of study medication to objective disease progression or death

Duration of Response (DOR)Up to 4 years and 6 months

DOR is defined as the time from the date that a confirmed objective response is first documented to the date of progressive disease (PD) or death due to any cause for those participants with a confirmed PR or CR.

Trial Locations

Locations (10)

St Vincent's Hospital

🇦🇺

Darlinghurst, New South Wales, Australia

Guangdong General Hospital

🇨🇳

Guangzhou, Guangdong, China

Sir Charles Gairdner Hospital

🇦🇺

Nedlands, Western Australia, Australia

Shanghai jiaotong university school of medicine Ruijin Hospital

🇨🇳

Shanghai, Shanghai, China

Harbin Medical University Cancer Hospital

🇨🇳

Harbin, Heilongjiang, China

Concord Hospital

🇦🇺

Sydney, New South Wales, Australia

Epworth Healthcare

🇦🇺

Richmond, Victoria, Australia

Royal Hobart Hospital

🇦🇺

Hobart, Tasmania, Australia

Monash Hospital

🇦🇺

Clayton, Victoria, Australia

Peter MacCallum Cancer Centre

🇦🇺

Melbourne, Victoria, Australia

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