NCT06540066

A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of BGB-B3227, a humanized immunoglobulin G1 (IgG1) antibody. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-B3227 as a monotherapy or in combination with tislelizumab with or without chemotherapy in participants with selected advanced or metastatic solid tumors. The study will also identify recommended dose(s) for expansion (RDFE\[s\]) of BGB-B3227 administered alone and in combination with tislelizumab.

Conditions

• Advanced Cancer
• Advanced Solid Tumor
• Metastatic Cancer
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	BGB-B3227	Administered intravenously.
DRUG	Tislelizumab	Administered intravenously.
DRUG	Chemotherapy	Administered in accordance with relevant local guidelines and/or prescribing information.

Timeline

• Start date: 2024-09-11
• Primary completion: 2026-01-09
• Completion: 2026-01-09
• First posted: 2024-08-06
• Last updated: 2026-03-16

Locations

12 sites across 3 countries: United States, China, Italy

Regulatory

• FDA-regulated drug study