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Trial record 1 of 1 for:    BGB-11417-201
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Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT05471843
Recruitment Status : Recruiting
First Posted : July 25, 2022
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Refractory Mantle Cell Lymphoma (MCL) Relapsed Mantle Cell Lymphoma Drug: BGB-11417 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Actual Study Start Date : September 5, 2022
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm
Participants will receive sonrotoclax
 Drug: BGB-11417
Administered orally
Other Name: sonrotoclax


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 1 Year ]
  2. Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation. [ Time Frame: Up to 5 Years ]
  3. Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events [ Time Frame: Up to 5 Years ]
  4. Part 2: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC) [ Time Frame: Up to 4 Years ]
    Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per the Lugano Classification


Secondary Outcome Measures :
  1. Part 1: Single Dose Area Under the Plasma Concentration Time Curve (AUC) [ Time Frame: Up to 2 Years ]
  2. Part 1: Single Dose Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to 2 Years ]
  3. Part 1: Single Dose Time to reach Cmax (Tmax) [ Time Frame: Up to 2 Years ]
  4. Part 1: Steady State Area Under the Plasma Concentration Time Curve (AUC) [ Time Frame: Up to 2 Years ]
  5. Part 1: Steady State Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to 2 Years ]
  6. Part 1: Steady State Trough Plasma Concentration (CTrough) [ Time Frame: Up to 2 Years ]
  7. Part 1: Steady State Time to reach Cmax (Tmax) [ Time Frame: Up to 2 Years ]
  8. Overall Response Rate (ORR) as assessed by investigator [ Time Frame: Up to 4 Years ]
    Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per Lugano classification

  9. Duration of Response (DOR) as assessed by investigator and IRC [ Time Frame: Up to 4 Years ]
    DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause; whichever occurs first

  10. Progression Free Survival (PFS) as assessed by investigator and IRC [ Time Frame: Up to 4 Years ]
    PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first.

  11. Time to Response (TTR) as assessed by investigator and IRC [ Time Frame: Up to 4 Years ]
    TTR is defined as the time from start of treatment to first documentation of response of Partial Response (PR) or better

  12. Overall Survival (OS) [ Time Frame: Up to 4 Years ]
    Defined as time from the start of treatment to the date of death due to any cause

  13. Part 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation. [ Time Frame: Up to 4 Years ]
  14. Part 2: Number of participants with clinically significant changes from baseline in vital signs [ Time Frame: Up to 4 Years ]
    Vital signs include blood pressure and pulse rate

  15. Part 2: Number of participants with clinically significant changes from baseline in clinical laboratory values [ Time Frame: Up to 4 Years ]
    Laboratory values include hematology, and clinical chemistry

  16. Part 2: Number of Participants With Clinically Significant Physical Examination Findings [ Time Frame: Up to 4 Years ]
    A Physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems

  17. Part 2: Participant Reported Outcomes as measured by NFLymSI-18 [ Time Frame: Up to 4 Years ]
    The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.

  18. Part 2: Participant Reported Outcomes as measured by EQ-5D-5L questionnaires [ Time Frame: Up to 4 Years ]
    The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Histologically confirmed diagnosis of MCL
  2. Prior systemic treatments for MCL (at least one line of anti-cluster of differentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one kind of covalent or non-covalent adequate Bruton Tyrosine Kinase (BTK) inhibitor).
  3. Relapsed/refractory disease
  4. Presence of measurable disease
  5. Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
  7. Adequate organ function

Key Exclusion Criteria:

  1. Known central nervous system involvement by lymphoma
  2. Prior malignancy other than MCL within the past 3 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.
  3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).
  4. Prior autologous stem cell transplant within the last 3 months; or prior autologous chimeric antigen receptor T-cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants.
  5. Clinically significant cardiovascular disease.
  6. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
  7. Active fungal, bacterial or viral infection requiring systemic treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05471843


Contacts
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Contact: BeiGene 1.877.828.5568 clinicaltrials@beigene.com

Locations
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Sponsors and Collaborators
BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT05471843    
Other Study ID Numbers: BGB-11417-201
CTR20221815 ( Other Identifier: ChinaDrugTrials )
First Posted: July 25, 2022    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
Mantle Cell Lymphoma
Lymphoma
MCL
 Refractory MCL
Refractory Mantle Cell Lymphoma
Relapsed Mantle Cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin