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Mature B-Cell MalignanciesPhase 1NCT04277637

Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies

A Phase 1 study testing Sonrotoclax, Zanubrutinib and Obinutuzumab in people with Mature B-Cell Malignancies, run by BeOne Medicines at 43 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mature B-Cell Malignancies
What is being tested?
Sonrotoclax, Zanubrutinib and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
437 participants
Where
43 sitesin 7 countries
Study dates
24 Mar 2020to 31 May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of one of the following:
  • NHL Cohorts:
  • MZL i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least one prior therapy ii. Active disease requiring treatment
  • FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy
  • DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least two prior systemic therapies and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy)
  • Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Part 1
Show all 21Show fewer
  • CLL/SLL Cohorts:
  • CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy ii. Requiring treatment as defined by history
  • MCL cohorts:
  • WHO-defined MCL i. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of the investigator
  • WM cohorts:
  • WHO-defined WM (clinical and definitive histologic diagnosis) i. R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy; ii. Meeting at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's Macroglobulinemia (Dimopoulos et al 2014)
  • Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI), defined as:
  • CLL: at least 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes measured by flow cytometry
  • DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node > 1.5 cm in longest diameter OR 1 extranodal lesion > 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is considered measurable for this study
  • WM: serum immunoglobulin (Ig) M level > 0.5 g/dL
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate organ function
  • Adequate pancreatic function indicated by:
  • Serum amylase ≤ 1.5 x upper limit of normal (ULN)
  • Serum lipase ≤ 1.5 x ULN

Who cannot join

  • Known current central nervous system involvement by lymphoma/leukemia
  • Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
  • Prior therapy ≥ 2 months with or progression on a B-cell lymphoma-2 (Bcl-2) inhibitor
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

43 sites in 7 countries.

43 sites in 7 countries

United States13 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Northwestern University

    Chicago, Illinois, 60611

  • The James Cancer Hospital and Solove Research Institute At Ohio State University

    Columbus, Ohio, 43210-1240

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Md Anderson Cancer Center

    Houston, Texas, 77030-3907

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160-8500

  • UCLA Hematologyoncology

    Los Angeles, California, 90095-3075

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York, 10065-6800

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Upmc Hillman Cancer Center(Univ of Pittsburgh)

    Pittsburgh, Pennsylvania, 15232-1309

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905-0001

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-4433

Other trials in United States

Australia12 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, SA 5000

  • Flinders Medical Centre

    Bedford PK, South Australia, SA 5042

  • Pindara Private Hospital

    Benowa, Queensland, QLD 4217

  • Box Hill Hospital

    Box Hill, Victoria, VIC 3128

  • Monash Health

    Clayton, Victoria, VIC 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, NSW 2139

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, VIC 3065

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000

  • The Alfred Hospital

    Melbourne, Victoria, VIC 3004

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009

  • Orange Health Service (Central West Cancer Care Centre)

    Orange, New South Wales, NSW 2800

  • John Flynn Private Hospital

    Tugun, Queensland, QLD 4224

Other trials in Australia

Spain7 sites

  • Vall D Hebron Institute of Oncology Vhio

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

  • Ico H Duran I Reynals

    Barcelona, 08907

  • Start Madrid Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

Other trials in Spain

Italy6 sites

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Ospedale Santa Maria Della Misericordia

    Perugia, 6129

  • Azienda Unita Sanitaria Locale Di Ravenna

    Ravenna, 48121

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Centroricerche Cliniche Di Verona Srl

    Verona, 37134

Other trials in Italy

New Zealand3 sites

  • North Shore Hospital

    Auckland, 0622

  • Auckland City Hospital

    Auckland, 1023

  • Wellington Regional Hospital (Ccdhb)

    Wellington, 6021

Other trials in New Zealand

Germany1 site

  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    Dresden, 01307

Other trials in Germany

United Kingdom1 site

  • The Leeds Teaching Hospitals Nhs Trust

    Leeds, LS9 7TF

Other trials in United Kingdom

About this study

Official title: A Phase 1a/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies

The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib and obinutuzumab.

Read the detailed description

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.

Being tested
Sonrotoclax, Zanubrutinib, Obinutuzumab
Keywords
NHL, BCL2 Inhibitor, CLL, MCL, MZL, SLL, WM, Bcl-2i, BTKi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SonrotoclaxDrug

    Also called BGB-11417

    Film-coated tablets administered once daily at a dose as specified in the treatment arm

  • ZanubrutinibDrug

    Also called BGB-3111

    320 mg daily administered as two 80-mg capsules twice a day (160 mg twice a day) or as four 80-mg capsules once a day (320 mg once a day)

  • ObinutuzumabDrug

    Given as an intravenous infusion administered per label.

Study groups in NCT04277637
Study groupRoleWhat they receive
Sonrotoclax Monotherapy Dose Finding: Part 1ExperimentalParticipants with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL) or transformed NHL, mantle cell lymphoma (MCL); Waldenströms macroglobulinemia (WM); and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) will receive oral sonrotoclax evaluated as monotherapy.
Receives: Drug: Sonrotoclax
Sonrotoclax Monotherapy Expansion Cohorts: Part 2ExperimentalParticipants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; CLL/SLL with low tumor burden or low creatine clearance; CLL/SLL with without high tumor burden or low creatine clearance will receive oral sonrotoclax at the RP2D dose to further define the safety profile.
Receives: Drug: Sonrotoclax
Sonrotoclax + Zanubrutinib Combination Therapy Dose Finding: Part 3ExperimentalParticipants with R/R MCL, R/R or treatment-naïve (TN) CLL/SLL will receive oral sonrotoclax in combination with zanubrutinib.
Receives: Drug: Sonrotoclax; Drug: Zanubrutinib
Sonrotoclax + Zanubrutinib Combination Therapy Dose Expansion: Part 4ExperimentalParticipants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; R/R MCL; R/R or treatment-naïve (TN) CLL/SLL will receive oral sonrotoclax in combination with zanubrutinib at an RP2D dose to further define the safety profile.
Receives: Drug: Sonrotoclax; Drug: Zanubrutinib
Sonrotoclax + Zanubrutinib Combination Therapy Dose Escalation: Part 5ExperimentalParticipants with treatment naïve CLL/SLL will receive oral sonrotoclax in combination with obinutuzumab without and with zanubrutinib.
Receives: Drug: Sonrotoclax; Drug: Zanubrutinib; Drug: Obinutuzumab
Sonrotoclax + Zanubrutinib Combination Therapy Dose Expansion: Part 6ExperimentalParticipants with treatment naïve CLL/SLL will receive oral sonrotoclax in combination with obinutuzumab without and with zanubrutinib at an RP2D dose to further define the safety profile.
Receives: Drug: Sonrotoclax; Drug: Zanubrutinib; Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to 30 days after the last dose of study drug, an average of 18 months

  2. Number of Participants Experiencing Serious Adverse Events (SAEs)

    Measured: Up to 30 days after the last dose of study drug, an average of 18 months

  3. Number of Participants Experiencing Adverse Events (AEs) leading to discontinuation of Sonrotoclax

    Measured: Up to 30 days after the last dose of study drug, an average of 18 months

  4. Part 1, Part 3: Maximum Tolerated Dose (MTD) of Sonrotoclax

    Measured: Up to approximately 2 months

  5. Part 1, Part 3, Part 5: RP2D of Sonrotoclax

    Measured: Day 1 to last dose of study drug, an average of 18 months

  6. Part 1, Part 3, Part 5: Number of participants experiencing tumor lysis syndrome (TLS) relevant events

    Measured: Up to 30 days after the last dose of study drug, an average of 18 months

  7. Part 1, Part 3, Part 5: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs

    Measured: Up to approximately 2 months

Secondary outcomes (20)

  1. Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Sonrotoclax

    Measured: Predose up to 12 hours postdose

  2. Area Under the Concentration-Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) After a Single Dose of Sonrotoclax

    Measured: Predose up to 12 hours postdose

  3. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) After a Single Dose of Sonrotoclax

    Measured: Predose up to 12 hours postdose

  4. Time Taken for Half the Initial Dose Administered to Be Eliminated from The Body (T1/2) of Sonrotoclax

    Measured: Predose up to 12 hours postdose

  5. Time to Maximum Plasma Concentration (Tmax) After a Single Dose of Sonrotoclax

    Measured: Predose up to 12 hours postdose

  6. Apparent Clearance (CL/F) After a Single Dose of Sonrotoclax

    Measured: Predose up to 12 hours postdose

  7. Apparent volume of distribution (Vz/F) After a Single Dose of Sonrotoclax

    Measured: Predose up to 12 hours postdose

  8. Steady State Area Under the Concentration-Time Curve of 0 - Last Day (AUCLast, ss) of Sonrotoclax

    Measured: Predose up to 12 hours postdose

  9. Part 3, Part 4: Steady State Area Under the Concentration-Time Curve of 0 - Last Day (AUCLast, ss) of zanubrutinib

    Measured: Predose up to 12 hours postdose

  10. Steady State Maximum Observed Plasma Concentration (Cmax, ss) of Sonrotoclax

    Measured: Predose up to 12 hours postdose

  11. Part 3, Part 4: Steady State Maximum Observed Plasma Concentration (Cmax, ss) of zanubrutinib

    Measured: Predose up to 12 hours postdose

  12. Steady State Trough Observed Plasma Concentration (Ctrough, ss) of Sonrotoclax

    Measured: Predose up to 12 hours postdose

  13. Part 3, Part 4: Steady State Trough Observed Plasma Concentration (Ctrough, ss) of zanubrutinib

    Measured: Predose up to 12 hours postdose

  14. Steady State Time to Maximum Plasma Concentration (Tmax, ss) of Sonrotoclax

    Measured: Predose up to 12 hours postdose

  15. Part 3, Part 4: Steady State Time to Maximum Plasma Concentration (Tmax, ss) of zanubrutinib

    Measured: Predose up to 12 hours postdose

  16. Part 2: AUC of Sonrotoclax administered after a high fat/calorie meal (HF-Fed)

    Measured: Predose up to 12 hours postdose

  17. Part 2: Cmax of Sonrotoclax administered after a high fat/calorie meal (HF-Fed)

    Measured: Predose up to 12 hours postdose

  18. Part 2, Part 4, Part 6: Overall Response Rate (ORR) as Assessed by the Investigator

    ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)

    Measured: Up to 18 months

  19. Part 2: Major Response Rate (MRR) for WM as Assessed by the Investigator

    Measured: Up to 18 months

  20. Part 6: Minimum residual disease (MRD) negativity as measured by next generation sequencing

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start24 Mar 2020
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04277637
Sponsor's protocol ID
BGB-11417-101
Other IDs
2024-515592-35-00, 2020-004641-37
Status last verified
Jun 2026
First submitted
18 Feb 2020
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sonrotoclax, Zanubrutinib and Obinutuzumab in people with Mature B-Cell Malignancies, run by BeOne Medicines at 43 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Australia, Spain, Italy, New Zealand and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 30 days after the last dose of study drug, an average of 18 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04277637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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