BGB-16673-104 - A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

Studio Clinico

Patologia: Linfomi, Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, I B, II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF
- Confirmed diagnosis of a R/R B-cell malignancy
- Protocol-defined measurable disease
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Adequate organ function
- Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment
- Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab

- Substudies 1, 3, and 4 Inclusion Criterion:
    - Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min

- Substudy 2 Inclusion Criteria:
    - Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression
    - Adequate renal function as indicated by eGFR of ≥ 30 mL/min

Criteri di esclusione: 

- Treatment-naive B-cell malignancies
- Unable to comply with the requirements of the protocol
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study or any locally recurring cancer that has been treated curatively
- Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening
- Substudies 1 and 2: Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent
- Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of BGB-16673, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab

Substudy 1 Exclusion Criterion:
    - Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen)

- Substudy 2 Exclusion Criterion:
    - Participants who discontinued prior zanubrutinib treatment due to intolerance

Substudies 3 and 4 Exclusion Criteria:
    - Prior exposure to a CD20 x CD3 T-cell engager antibody treatment
    - All participants with a prior allogeneic stem cell transplant

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

Trattamento sperimentale: 

BGB-16673 (Bruton Tyrosine Kinase-Targeted Protein-Degrader) in combinazione con altri agenti

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-516234-35-00

Data di inserimento: 21.11.2025

Promotore

BeOne Medicines

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na