AzTrials
AzTrials

Mature B-cell MalignanciesPhase 1NCT04883957

Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies

A Phase 1 study testing BGB-11417 in people with Mature B-cell Malignancies, run by BeiGene at 11 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety and tolerability of BGB-11417 monotherapy, define the maximum tolerated dose (MTD) or maximum administered dose and the recommended Phase 2 dose (RP2D) of BGB-11417 monotherapy for the selected B-cell malignancy dose finding cohorts, and evaluate the safety and… 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?
BGB-11417
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
11 sitesChina
Study dates
5 Jul 2021to 1 Sep 2026
Phase
Phase 1

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 only one of the following:
  • Cohort A
  • Marginal Zone Lymphoma
  • R/R extranodal, splenic or nodal disease defined as disease that has relapsed after, or been refractory to, ≥ 1 line of anti-CD20 antibody-based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for MZL is available per investigator's assessment.
  • Active disease requiring treatment.
  • Follicular Lymphoma
Show all 21Show fewer
  • 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 has relapsed after, or been refractory to, ≥ 1 line of anti-CD20 antibody-based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for FL is available per investigator's assessment.
  • Active disease requiring treatment.
  • Diffuse Large B-cell Lymphoma
  • R/R DLBCL defined as disease that relapsed after, or been refractory to, at least one line of anti-CD20 antibody based chemoimmunotherapy for ≥ 2 consecutive cycles, and no effective standard therapy for DLBCL is available per investigator's assessment.
  • Active disease requiring treatment.
  • Transformed indolent B-cell NHL
  • Any lymphoma otherwise eligible for Cohort A that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Cohort A.
  • Active disease requiring treatment.
  • Cohorts B and C
  • CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria:
  • R/R disease defined as disease that has relapsed after, or been refractory to, ≥ 1 line of standard therapy for ≥ 2 consecutive cycles, and no effective standard therapy is available per investigator's assessment.
  • Requiring treatment based on IWCLL criteria.
  • Measurable disease by computed tomography/magnetic resonance imaging, defined as:
  • CLL: At least 1 lymph node > 1.5 centimeters (cm) in longest diameter and measurable in 2 perpendicular dimensions. For Cohort B, participants should not meet with the definition of high tumor burden, which is required for participants enrolled in Cohort C.
  • DLBCL, FL, MZL, 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 2 perpendicular dimensions. For MZL isolated splenomegaly is considered to indicate measurable disease for this study. For SLL, participants in Cohort B should not meet with the definition of high tumor burden, which is required for participants enrolled in Cohort C.

Who cannot join

  • Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer.
  • Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results.
  • Known central nervous system involvement by lymphoma/leukemia.
  • Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome.
  • Prior autologous stem cell transplant unless ≥ 3 months after transplant; or prior chimeric cell therapy unless ≥ 6 months after cell infusion.
  • Prior allogeneic stem cell transplant.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shenzhen Peoples Hospital

    Shenzhen, Guangdong, 518020

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Bcl-2 Inhibitor BGB-11417 in Adult Patients With Mature B-cell Malignancies

The purpose of this study is to evaluate the safety and tolerability of BGB-11417 monotherapy, define the maximum tolerated dose (MTD) or maximum administered dose and the recommended Phase 2 dose (RP2D) of BGB-11417 monotherapy for the selected B-cell malignancy dose finding cohorts, and evaluate the safety and tolerability of the ramp-up dosing schedule in the evaluated disease types.

Read the detailed description

This study will have 3 cohorts for determining a monotherapy MTD and ramp-up schedule: Cohort A, participants with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R NHL); Cohort B, participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with low tumor burden; Cohort C, participants with R/R CLL/SLL with high tumor burden.

Being tested
BGB-11417
Keywords
BGB-11417, Bcl-2, Pharmacokinetics, RP2D, MTD

What participants receive

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

  • BGB-11417Drug

    Also called Sonrotoclax

    Film-coated tablets administered orally as specified in the treatment arm.

Study groups in NCT04883957
Study groupRoleWhat they receive
Cohort A: R/R NHLExperimentalParticipants with R/R NHL, including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL), or transformed NHL, will receive oral BGB-11417 until the MTD (or maximum ascending dose [MAD]) and the RP2D can be determined.
Receives: Drug: BGB-11417
Cohort B: R/R CLL/SLL (low tumor burden)ExperimentalParticipants with low tumor burden R/R CLL/SLL will receive oral BGB-11417 until the MTD (or MAD) and the RP2D can be determined.
Receives: Drug: BGB-11417
Cohort C: R/R CLL/SLL (high tumor burden)ExperimentalParticipants in this cohort will not be enrolled until the RP2D for Cohort B is established. Participants will be treated with the monotherapy ramp-up schedule and the RP2D established in Cohort B.
Receives: Drug: BGB-11417

What is being measured

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

  1. MTD Of BGB-11417 As Recommended By The Bayesian Logistic Regression Model Or The MAD

    Measured: Approximately 3 years

  2. RP2D Of BGB-11417

    The RP2D will be decided by the sponsor and based on the safety monitoring committee recommendation considering totality of data.

    Measured: Approximately 3 years

  3. Incidence And Severity Of Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events (AEs) Leading To Discontinuation, And Dose-Limiting Toxicities (DLTs)

    All AEs, including DLT events, will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (or the Grading Scale for Hematologic Toxicity in CLL Studies as appropriate).

    Measured: Approximately 3 years

  4. Incidence And Severity Of Tumor Lysis Syndrome-relevant Events

    Measured: Approximately 3 years

Secondary outcomes (12)

  1. Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of BGB-11417

    Measured: Up to 24 hours postdose

  2. PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) Of BGB-11417

    Measured: Up to 24 hours postdose

  3. PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) Of BGB-11417

    Measured: Up to 24 hours postdose

  4. PK As Assessed By Time To Maximum Observed Plasma Concentration (tmax) Of BGB-11417

    Measured: Up to 24 hours postdose

  5. PK As Assessed By Terminal Half-life (t1/2) Of BGB-11417

    Measured: Up to 24 hours postdose

  6. PK As Assessed By Apparent Total Clearance Of Drug From Plasma After Oral Administration (CL/F) Of BGB-11417

    Measured: Up to 24 hours postdose

  7. PK As Assessed By Apparent Volume Of Distribution (Vz/F) Of BGB-11417

    Measured: Up to 24 hours postdose

  8. PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To Last Measurable Concentration At Steady State (AUClast,ss) Of BGB-11417

    Measured: Up to 24 hours postdose

  9. PK As Assessed By Maximum Observed Plasma Concentration At Steady State (Cmax,ss) Of BGB-11417

    Measured: Up to 24 hours postdose

  10. PK As Assessed By Trough Concentration At Steady State (Ctrough,ss) Of BGB-11417

    Measured: Up to 24 hours postdose

  11. PK As Assessed By Time To Maximum Observed Plasma Concentration At Steady State (tmax,ss) Of BGB-11417

    Measured: Up to 24 hours postdose

  12. Overall Response Rate (ORR) Of BGB-11417 Monotherapy

    ORR will be assessed per disease-specific response assessment guidelines as determined by the investigator.

    Measured: Approximately 3 years

Timeline

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

  1. First posted12 May 2021
  2. Study start5 Jul 2021
  3. Primary completion1 Sep 2026
  4. Study completion1 Sep 2026

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
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04883957
Sponsor's protocol ID
BGB-11417-102
Other IDs
CTR20211017
Status last verified
Sep 2026
First submitted
7 May 2021
Last updated
28 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in