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Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia

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ClinicalTrials.gov Identifier: NCT05952037
Recruitment Status : Recruiting
First Posted : July 19, 2023
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.

Condition or disease Intervention/treatment Phase
Waldenstrom Macroglobulinemia Waldenstrom's Macroglobulinemia Recurrent Waldenstrom's Macroglobulinemia Refractory Drug: BGB-11417 Phase 2

Detailed Description:

This study will test whether BGB-11417 can be used to improve outcomes in participants with Waldenström's Macroglobulinemia (WM) who have not responded well to conventional treatments. The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment, and to determine what adverse events, or side effects, participants might experience.

BCL2 is a key protein involved in cell death, and abnormal levels of BCL2 are associated with many cancers. Blocking the action of BCL2 proteins is a promising approach with potential therapeutic benefits in participants with different types of cancers, including WM. This study will enroll approximately 85 patients. All patients will receive BGB-11417 orally as a tablet.

The study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 5 years. Treatments will continue until participants experience worsening disease status, too many side effects, or withdraw consent.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia
Actual Study Start Date : September 28, 2023
Estimated Primary Completion Date : November 2027
Estimated Study Completion Date : September 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Participants with R/R disease to both Bruton tyrosine kinase (BTK) inhibitor and anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor will receive BGB-11417 at a standard dose, given orally once daily.
 Drug: BGB-11417
Administered orally as a tablet.
Other Name: Sonrotoclax
Experimental: Cohort 2
Participants with R/R disease to anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor and were intolerant to BTK inhibitor will receive BGB-11417 at a standard dose, given orally once daily.
 Drug: BGB-11417
Administered orally as a tablet.
Other Name: Sonrotoclax
Experimental: Cohort 3
Participants with R/R disease to a BTK inhibitor treatment and are unsuitable for chemoimmunotherapy will receive BGB-11417 at a standard dose, given orally once daily.
 Drug: BGB-11417
Administered orally as a tablet.
Other Name: Sonrotoclax


Outcome Measures
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Primary Outcome Measures :
  1. Major Response Rate (MRR) in Cohort 1 [ Time Frame: Up to approximately 4 years ]
    MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the Independent Review Committee (IRC).


Secondary Outcome Measures :
  1. MRR in Cohorts 1, 2, and 3 [ Time Frame: Up to approximately 5 years ]
    MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the investigator (Cohorts 1, 2, and 3) and by the IRC (Cohorts 2 and 3).

  2. Duration of Response (DOR) [ Time Frame: Up to approximately 5 years ]
    DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC and by the investigator.

  3. CR + VGPR rate [ Time Frame: Up to approximately 5 years ]
    CR + VGPR is defined as the percentage of participants who achieve CR or VGPR, as assessed by the IRC and by the investigator.

  4. Overall Response Rate (ORR) [ Time Frame: Up to approximately 5 years ]
    ORR is defined as the percentage of participants with minor response (MR) or better, as assessed by the IRC and by the investigator.

  5. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 5 years ]
    PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC and by the investigator.

  6. Time to major response [ Time Frame: Up to approximately 5 years ]
    Time to major response is defined as the time from start of study treatment to the first documentation of major response, as assessed by the IRC and by the investigator.

  7. Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]
    OS is defined as the time from first study drug administration to the date of death due to any cause.

  8. Number of participants reporting adverse events [ Time Frame: Up to approximately 5 years ]
    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities, physical examination results, and vital signs.

  9. Health-Related Quality of Life (HRQoL): NFLymSI-18 [ Time Frame: Up to approximately 5 years ]
    HRQoL based on participant-reported outcomes using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 Item (NFLymSI-18) Version 4. The 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Clinical and definitive histologic diagnosis of WM.
  • Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM).
  • Refractory or relapsed disease to the most recent therapy at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.
  • Adequate organ function.

Exclusion Criteria:

  • Central nervous system (CNS) involvement by WM.
  • Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.
  • History of other malignancies ≤ 2 years before study entry.
  • Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug.

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): NCT05952037


Contacts
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Contact: Study Director 1-877-828-5568 clinicaltrials@beigene.com

Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Study Director BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT05952037    
Other Study ID Numbers: BGB-11417-203
U1111-1291-4524 ( Registry Identifier: World Health Organization )
2023-503235-18 ( EudraCT Number )
CTR20232718 ( Registry Identifier: ChinaDrugTrials )
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: April 24, 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:
Waldenström's macroglobulinemia
Waldenstrom's Macroglobulinemia Recurrent
Waldenstrom's Macroglobulinemia Refractory
Lymphoma
Additional relevant MeSH terms:
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Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases