NCT02343120 is a Phase 1, PHASE2 clinical trial of Zanubrutinib in B-cell Malignancies, sponsored by BeiGene.

Who is sponsoring NCT02343120?

NCT02343120 is sponsored by BeiGene.

What drugs are being tested in NCT02343120?

Interventions in NCT02343120: Zanubrutinib.

What condition does NCT02343120 study?

NCT02343120 studies B-cell Malignancies.

Is NCT02343120 still recruiting?

NCT02343120 is currently completed. Last updated 28 April 2022.

Are results published for NCT02343120?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-04-28 · How we verify

NCT02343120

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies

Completed Phase 1, PHASE2 Results posted Last updated 28 April 2022

What this trial tests

Phase 1, PHASE2 trial testing Zanubrutinib in B-cell Malignancies in 385 participants. Completed in 31 March 2021.

Timeline

4 September 2014

Primary endpoint
31 March 2021

31 March 2021

Quick facts

Lead sponsor	BeiGene
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	385
Start date	4 September 2014
Primary completion	31 March 2021
Estimated completion	31 March 2021
Sites	23 locations across Italy, New Zealand, United Kingdom, South Korea, Australia, United States

Drugs / interventions tested

Zanubrutinib (ZANUBRUTINIB) — full drug profile →

Conditions studied

B-cell Malignancies — all drugs for B-cell Malignancies →

Sponsor

BeiGene — full company profile →

Who can join

18 and older, any sex, with B-cell Malignancies. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1 and Part 2: Number of Participants With Adverse Events Primary · Up to approximately 6 years and 7 months

Number of participants with adverse events and serious adverse events, including clinically relevant physical examinations and laboratory measurements

At least one treatment-emergent adverse event

Group	Value	95% CI
Part 1: 40 mg QD	3
Part 1: 80 mg QD	4
Part 1: 160 mg QD	5
Parts 1 and 2: 160 mg BID	274
Parts 1 and 2: 320 mg QD	94

Serious adverse events

Group	Value	95% CI
Part 1: 40 mg QD	1
Part 1: 80 mg QD	2
Part 1: 160 mg QD	3
Parts 1 and 2: 160 mg BID	157
Parts 1 and 2: 320 mg QD	45

Part 1: Recommended Phase 2 Dose (RP2D) for Zanubrutinib Primary · Month 9

RP2D for zanubrutinib was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 320 mg QD

Group	Value	95% CI
Part 1: Zanubrutinib	320

Part 1 and Part 2: Area Under the Curve From Time 0 to the Last Sampling Time Point Within the Dose Interval (AUClast) of Zanubrutinib Secondary · Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours

Group	Value	95% CI
Part 1: 40 mg QD	274.7	± 47.8
Part 1: 80 mg QD	436.8	± 103.5
Part 1: 160 mg QD	1480	± 53.0
Parts 1 and 2: 160 mg BID	1132	± 61.1
Parts 1 and 2: 320 mg QD	2281	± 60.5

Part 1 and Part 2: Area Under the Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Zanubrutinib Secondary · Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours

Group	Value	95% CI
Part 1: 40 mg QD	301.1	± 51.5
Part 1: 80 mg QD	460.0	± 100.6
Part 1: 160 mg QD	1505	± 52.7
Part 1 and Part 2: 160 mg BID	1253	± 59.0
Part 1 and Part 2: 320 mg QD	2538	± 47.8

Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib Secondary · Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours

Group	Value	95% CI
Part 1: 40 mg QD	86.0	± 46.6
Part 1: 80 mg QD	125	± 77.6
Part 1: 160 mg QD	397	± 76.1
Part 1 and Part 2: 160 mg BID	304	± 63.8
Part 1 and Part 2: 320 mg QD	566	± 65.6

Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib Secondary · Week 2 Day 1 pre-dose and 24 hours

Group	Value	95% CI
Part 1: 40 mg QD	75.7	± 36.2
Part 1: 80 mg QD	169	± 50.0
Part 1: 160 mg QD	387	± 60.7
Part 1 and Part 2: 160 mg BID	299	± 56.1
Part 1 and Part 2: 320 mg QD	533	± 55.0

Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib Secondary · Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours

Group	Value	95% CI
Part 1: 40 mg QD	1.00	0.50 – 1.98
Part 1: 80 mg QD	2.00	1.17 – 2.00
Part 1: 160 mg QD	1.92	0.93 – 2.08
Part 1 and Part 2: 160 mg BID	2.00	0.83 – 8.00
Part 1 and Part 2: 320 mg QD	2.00	0.72 – 3.08

Part 1 and Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Zanubrutinib Secondary · Week 2 Day 1 pre-dose and 24 hours

Group	Value	95% CI
Part 1: 40 mg QD	2.00	2.00 – 2.00
Part 1: 80 mg QD	2.50	1.08 – 3.00
Part 1: 160 mg QD	2.00	1.00 – 3.17
Part 1 and Part 2: 160 mg BID	2.00	0.53 – 6.00
Part 1 and Part 2: 320 mg QD	2.00	0.33 – 6.00

Part 1 and Part 2: Apparent Terminal Half-life (t1/2) of Zanubrutinib Secondary · Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours

Group	Value	95% CI
Part 1: 40 mg QD	1.94	± 28.5
Part 1: 80 mg QD	1.97	± 29.8
Part 1: 160 mg QD	3.87	± 24.9
Part 1 and Part 2: 160 mg BID	2.73	± 60.2
Part 1 and Part 2: 320 mg QD	3.30	± 61.2

Part 1 and Part 2: Apparent Clearance (CL/F) of Zanubrutinib Secondary · Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours

Group	Value	95% CI
Part 1: 40 mg QD	133	± 51.5
Part 1: 80 mg QD	174	± 100.6
Part 1: 160 mg QD	106	± 52.7
Part 1 and Part 2: 160 mg BID	128	± 59.4
Part 1 and Part 2: 320 mg QD	126	± 47.8

Part 1 and Part 2: Apparent Volume of Distribution of Zanubrutinib During the Terminal Phase (Vz/F) Secondary · Week 1 Day 1 pre-dose, 0.5, 1, 2, 3, 4, and 8 hours

Group	Value	95% CI
Part 1: 40 mg QD	371	± 47.5
Part 1: 80 mg QD	494	± 78.9
Part 1: 160 mg QD	593	± 61.6
Part 1 and Part 2: 160 mg BID	530	± 70.0
Part 1 and Part 2: 320 mg QD	600	± 97.6

Part 1 and Part 2: Overall Response Rate (ORR) Secondary · Up to 6 years and 7 months

ORR is defined as the percentage of participants with partial or complete response (CR), as assessed by the investigator. For CLL/SLL, ORR includes partial response (PR) with lymphocytosis (PR-L) or better (includes PR-L, PR, nodular PR or nPR and CR with incomplete marrow recovery or CRi) and for MW, ORR includes minor response or better. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL

CLL/SLL

Group	Value	95% CI
Part 1 and Part 2: Overall	95.2	89.8 – 98.2

Group	Value	95% CI
Part 1 and Part 2: Overall	95.9	88.5 – 99.1

MCL

Group	Value	95% CI
Part 1 and Part 2: Overall	82.5	70.1 – 91.3

MZL

Group	Value	95% CI
Part 1 and Part 2: Overall	85.0	62.1 – 96.8

Group	Value	95% CI
Part 1 and Part 2: Overall	36.4	20.4 – 54.9

DLBCL

Group	Value	95% CI
Part 1 and Part 2: Overall	42.2	27.7 – 57.8

Group	Value	95% CI
Part 1 and Part 2: Overall	61.5	31.6 – 86.1

HCL

Group	Value	95% CI
Part 1 and Part 2: Overall	58.3	27.7 – 84.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 6 years and 7 months. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: 40 mg QD

Serious: 1/3 (33%)

Deaths: 1/3

Part 1: 80 mg QD

Serious: 2/4 (50%)

Deaths: 2/4

Part 1: 160 mg QD

Serious: 3/5 (60%)

Deaths: 2/5

Part 1 and Part 2: 160 mg BID

Serious: 157/278 (56%)

Deaths: 76/278

Part 1 and Part 2: 320 mg QD

Serious: 45/95 (47%)

Deaths: 19/95

Serious adverse events (231 terms)

Reaction	System	Part 1: 40 mg QD	Part 1: 80 mg QD	Part 1: 160 mg QD	Part 1 and Part 2: 160 mg …	Part 1 and Part 2: 320 mg QD
Pneumonia	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—
Lower respiratory tract infection	Infections and infestations	—	—	—	—	—
Meningitis cryptococcal	Infections and infestations	—	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—

Other adverse events (190 terms — click to expand)

Reaction	System	Part 1: 40 mg QD	Part 1: 80 mg QD	Part 1: 160 mg QD	Part 1 and Part 2: 160 mg …	Part 1 and Part 2: 320 mg QD
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Lower respiratory tract infection	Infections and infestations	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Petechiae	Skin and subcutaneous tissue disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Urinary tract infection, Pyrexia, Cellulitis, Febrile neutropenia, Anaemia, Diarrhoea, Pleural effusion.

Data from ClinicalTrials.gov NCT02343120 adverse events section.

Sponsor's own description

This study evaluated the safety, tolerability, pharmacokinetic profile and efficacy of BGB-3111 in participants with B-cell lymphoid malignancies.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL.
Tam CS, Trotman J, Opat S, Burger JA, et al · · 2019 · cited 280× · PMID 31340982 · DOI 10.1182/blood.2019001160
Treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma with the BTK inhibitor zanubrutinib: phase 2, single-arm, multicenter study.
Xu W, Yang S, Zhou K, Pan L, et al · · 2020 · cited 99× · PMID 32393328 · DOI 10.1186/s13045-020-00884-4
Advances in targeted therapy for malignant lymphoma.
Wang L, Qin W, Huo YJ, Li X, et al · · 2020 · cited 88× · PMID 32296035 · DOI 10.1038/s41392-020-0113-2
Zanubrutinib for the treatment of patients with Waldenström macroglobulinemia: 3 years of follow-up.
Trotman J, Opat S, Gottlieb D, Simpson D, et al · · 2020 · cited 84× · PMID 32698195 · DOI 10.1182/blood.2020006449
Zanubrutinib for the treatment of relapsed or refractory mantle cell lymphoma.
Tam CS, Opat S, Simpson D, Cull G, et al · · 2021 · cited 77× · PMID 34152395 · DOI 10.1182/bloodadvances.2020004074
Ibrutinib Resistance Mechanisms and Treatment Strategies for B-Cell lymphomas.
George B, Chowdhury SM, Hart A, Sircar A, et al · · 2020 · cited 77× · PMID 32455989 · DOI 10.3390/cancers12051328
Bruton Tyrosine Kinase Inhibitors in B-Cell Malignancies: Their Use and Differential Features.
Shirley M. · · 2022 · cited 64× · PMID 34905129 · DOI 10.1007/s11523-021-00857-8
Current and future treatment strategies in chronic lymphocytic leukemia.
Patel K, Pagel JM. · · 2021 · cited 60× · PMID 33902665 · DOI 10.1186/s13045-021-01054-w

Verify or expand the search:

Other trials of Zanubrutinib

Trials testing the same drug.

NCT07341191 — Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR · Phase 2 · not yet recruiting
NCT06859008 — Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Rel · Phase 1 · recruiting
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C · Phase 3 · not yet recruiting
NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies · not yet recruiting

Other recruiting trials for B-cell Malignancies

Currently open trials in the same condition.

NCT07349849 — Exploratory Study on mRNA Therapeutic Drug Targeting CD19 for the Treatment of Hematologic Malignancies · EARLY_PHASE1 · recruiting
NCT03125577 — Combination CAR-T Cell Therapy Targeting Hematological Malignancies · Phase 1, PHASE2 · recruiting
NCT03050190 — A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies · Phase 1, PHASE2 · recruiting
NCT06958679 — Evaluation of SYS6005 in Patients With Advanced Malignant Tumor · Phase 1 · recruiting
NCT06542250 — A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R · Phase 1, PHASE2 · recruiting

Other BeiGene trials

Trials by the same sponsor.

NCT07169331 — A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglob · Phase 4 · recruiting
NCT07100938 — A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheum · Phase 2 · active not recruiting
NCT07005713 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB- · Phase 1 · active not recruiting
NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants · Phase 1 · completed
NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02343120 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 28 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02343120.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing