The trial is taking place at:
H

Hospital Aleman | Department of Cardiology Service

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

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Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Mantle Cell Lymphoma
Relapsed Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma (MCL)

Treatments

Drug: BGB-11417

Study type

Interventional

Funder types

Industry

Identifiers

NCT05471843
CTR20221815 (Other Identifier)
BGB-11417-201

Details and patient eligibility

About

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.

Enrollment

122 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

122 participants in 1 patient group

Single Arm
Experimental group
Description:
Participants will receive sonrotoclax
Treatment:
Drug: BGB-11417

Trial contacts and locations

105

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Central trial contact

BeiGene

Data sourced from clinicaltrials.gov

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