BGB-B3227-101 - A Multicenter, Open-label, Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B3227 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced or Metastatic Solid Tumors

Studio Clinico

Patologia: Carcinoma del pancreas esocrino, Neoplasie della mammella, Neoplasie del polmone, Tumori del colon retto, Tumori dell’ovaio, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Randomizzato: No

Fase di studio: 1, I A, I B

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Histologically or cytologically confirmed locally advanced or metastatic solid tumors with a high prevalence of mucin-1 (MUC1) expression
- At least 1 measurable lesion per RECIST v1.1
- Stable Eastern Cooperative Oncology Group Performance Status of ≤ 1
- Adequate organ function
- Willing to use a highly effective method of birth control.

Criteri di esclusione: 

- History of prior ≥ Grade 3 Cytokine Release Syndrome (CRS)
- History of severe Infusion-Related Reactions (IRRs), allergic reactions, or hypersensitivity to any ingredients or components of the study treatments
- Infection requiring systemic (oral or intravenous) therapy ≤ 14 days before the first dose of study drug(s), or participants with symptomatic COVID-19 infection
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune disease or history of autoimmune disease(s) that may relapse

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

Trattamento sperimentale: 

BGB-B3227 monotherapy o in combinazione con Tislelizumab (A317)

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-514216-27-00

Data di inserimento: 24.04.2025

Promotore

BeiGene

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na