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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04883957
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE May 7, 2021
First Posted Date  ICMJE May 12, 2021
Last Update Posted Date June 1, 2023
Actual Study Start Date  ICMJE July 5, 2021
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2021)
  • MTD Of BGB-11417 As Recommended By The Bayesian Logistic Regression Model Or The MAD [ Time Frame: Approximately 3 years ]
  • RP2D Of BGB-11417 [ Time Frame: Approximately 3 years ]
    The RP2D will be decided by the sponsor and based on the safety monitoring committee recommendation considering totality of data.
  • Incidence And Severity Of Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events (AEs) Leading To Discontinuation, And Dose-Limiting Toxicities (DLTs) [ Time Frame: Approximately 3 years ]
    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).
  • Incidence And Severity Of Tumor Lysis Syndrome-relevant Events [ Time Frame: Approximately 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2021)
  • Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 24 hours postdose ]
  • PK As Assessed By Time To Maximum Observed Plasma Concentration (tmax) Of BGB-11417 [ Time Frame: Up to 24 hours postdose ]
  • PK As Assessed By Terminal Half-life (t1/2) Of BGB-11417 [ Time Frame: Up to 24 hours postdose ]
  • PK As Assessed By Apparent Total Clearance Of Drug From Plasma After Oral Administration (CL/F) Of BGB-11417 [ Time Frame: Up to 24 hours postdose ]
  • PK As Assessed By Apparent Volume Of Distribution (Vz/F) Of BGB-11417 [ Time Frame: Up to 24 hours postdose ]
  • 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 [ Time Frame: Up to 24 hours postdose ]
  • PK As Assessed By Maximum Observed Plasma Concentration At Steady State (Cmax,ss) Of BGB-11417 [ Time Frame: Up to 24 hours postdose ]
  • PK As Assessed By Trough Concentration At Steady State (Ctrough,ss) Of BGB-11417 [ Time Frame: Up to 24 hours postdose ]
  • PK As Assessed By Time To Maximum Observed Plasma Concentration At Steady State (tmax,ss) Of BGB-11417 [ Time Frame: Up to 24 hours postdose ]
  • Overall Response Rate (ORR) Of BGB-11417 Monotherapy [ Time Frame: Approximately 3 years ]
    ORR will be assessed per disease-specific response assessment guidelines as determined by the investigator.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of BGB-11417 in Adult Participants With Mature B-cell Malignancies
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mature B-cell Malignancies
Intervention  ICMJE Drug: BGB-11417
Film-coated tablets administered orally as specified in the treatment arm.
Study Arms  ICMJE
  • Experimental: Cohort A: R/R NHL
    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.
    Intervention: Drug: BGB-11417
  • Experimental: Cohort B: R/R CLL/SLL (low tumor burden)
    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.
    Intervention: Drug: BGB-11417
  • Experimental: Cohort C: R/R CLL/SLL (high tumor burden)
    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.
    Intervention: Drug: BGB-11417
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 18, 2023)
70
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2021)
40
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. 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

    a. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria:

    i. 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.

    ii. Requiring treatment based on IWCLL criteria.

  2. Measurable disease by computed tomography/magnetic resonance imaging, defined as:

    1. 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.
    2. 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.

Key Exclusion Criteria:

  1. 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.
  2. 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.
  3. Known central nervous system involvement by lymphoma/leukemia.
  4. Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome.
  5. Prior autologous stem cell transplant unless ≥ 3 months after transplant; or prior chimeric cell therapy unless ≥ 6 months after cell infusion.
  6. Prior allogeneic stem cell transplant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04883957
Other Study ID Numbers  ICMJE BGB-11417-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party BeiGene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BeiGene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lu Zhang, M.D. BeiGene (Suzhou) Co., Ltd.
PRS Account BeiGene
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP