A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

Overview

Información sobre este estudio

This study consists of two parts to explore BGB-16673 recommended dosing:  a part 1 monotherapy dose finding and a part 2 (cohort expansion in two cohorts).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria :

1. Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection

2. Age ≥ 18 years

3. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following: a. Patients with MZL (Parts 1a, 1b, and 1c only) and all of the following: i. Extranodal, splenic, or nodal MZL ii. R/R MZL is defined as disease that relapsed after, or was refractory to, ≥ 2 prior lines of therapy (a line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen) (1) For patients enrolling at US sites ONLY: patients must have been treated with a covalently-binding BTK inhibitor and an anti-CD20 monoclonal antibody in any line of therapy to be eligible for the study. (2) For patients enrolling at EU sites ONLY: patients must have been treated with an anti-CD20 monoclonal antibody in any line of therapy to be eligible for the study. iii. Active disease requiring treatment.

4. Patients who have previously received a covalently-binding BTK inhibitor in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).

5. For dose-finding and dose-expansion, patients who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following
criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.

6. Measurable disease by radiographic assessment or serum IgM level (WM only)

7. ECOG Performance Status of 0 to 2

8. Patients enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of
enrollment; patients with CLL/SLL or MCL enrolling in the expansion cohorts (Part 2) must have been treated with a BTKi in a prior line of therapy.

Exclusion Criteria:

1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer,
carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer 

2. Requires ongoing systemic treatment for any other malignancy

3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.

4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or
biopsy) by B-cell malignancy, regardless of whether patient had received treatment for central nervous system disease

5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, GCB
DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary
mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC
and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin
lymphoma, or history of or currently suspected Richter's transformation of an indolent lymphoma to an aggressive histology (only patients with Richter Transformation to
DLBCL are eligible for Part 1a).

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

Eligibility last updated 5/19/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Yucai Wang, M.D., Ph.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Talal Hilal, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Ricardo Parrondo, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

Preguntas de estudios clínicos para pacientes internacionales