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NCT Number: NCT05471843

Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Mantle Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Refractory Mantle Cell Lymphoma (MCL) Relapsed Mantle Cell Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Aleman, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of MCL
  • 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).
  • Relapsed/refractory disease
  • Presence of measurable disease
  • Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
  • Adequate organ function

Key Exclusion Criteria:

  • Known central nervous system involvement by lymphoma
  • 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.
  • Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).
  • 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.
  • Clinically significant cardiovascular disease.
  • Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
  • Active fungal, bacterial or viral infection requiring systemic treatment.

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

Treatment and study plan

BGB-11417

Drug

Administered orally

Other names: sonrotoclax

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jul 25, 2022
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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