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

NCT04883957 | Active Not Recruiting Phase 1

• 2 other identifiers: BGB-11417-102CTR20211017
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 11

Brief 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 tolerability of the ramp-up dosing schedule in the evaluated disease types.

Conditions

Mature B-cell Malignancies

Keywords

BGB-11417; Bcl-2; Pharmacokinetics; RP2D; MTD

Outcome Measures

Primary Outcomes (4)

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

  Approximately 3 years

• RP2D Of BGB-11417

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

  Approximately 3 years

• 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).

  Approximately 3 years

• Incidence And Severity Of Tumor Lysis Syndrome-relevant Events

  Approximately 3 years

Secondary Outcomes (12)

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

  Up to 24 hours postdose

• 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

  Up to 24 hours postdose

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

  Up to 24 hours postdose

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

  Up to 24 hours postdose

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

  Up to 24 hours postdose

Study Arms (3)

Cohort A: R/R NHL

EXPERIMENTAL

Participants 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.

Drug: BGB-11417

Cohort B: R/R CLL/SLL (low tumor burden)

EXPERIMENTAL

Participants with low tumor burden R/R CLL/SLL will receive oral BGB-11417 until the MTD (or MAD) and the RP2D can be determined.

Drug: BGB-11417

Cohort C: R/R CLL/SLL (high tumor burden)

EXPERIMENTAL

Participants 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.

Drug: BGB-11417

Interventions

BGB-11417 DRUG

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

Also known as: Sonrotoclax

Cohort A: R/R NHL; Cohort B: R/R CLL/SLL (low tumor burden); Cohort C: R/R CLL/SLL (high tumor burden)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of only one of the following:
• Cohort A
• a. Marginal Zone Lymphoma
• i. 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.
• ii. Active disease requiring treatment.
• b. Follicular Lymphoma
• 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 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.
• ii. Active disease requiring treatment.
• c. Diffuse Large B-cell Lymphoma
• i. 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.
• ii. Active disease requiring treatment.
• d. Transformed indolent B-cell NHL
• i. 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.
• ii. Active disease requiring treatment.
• Cohorts B and C

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (11)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University Peoples Hospital

Beijing, Beijing Municipality, 100044, China

Location

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Shenzhen Peoples Hospital

Shenzhen, Guangdong, 518020, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

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

Wuhan, Hubei, 430030, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, 330006, China

Location

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Study Officials

• Lu Zhang, M.D.

  BeiGene (Suzhou) Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: July 5, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (11)