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

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT05471843RENIS: IS004403Tipo: INTERVENTIONALInicio: 5 de sept de 2022Fin estimado: 31 de ene de 2027

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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.

Intervenciones

drug

BGB-11417

Administered orally

Ubicaciones

Hospital Aleman

Buenos Aires, Argentina

Patrocinadores

PrincipalBeiGene

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