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

NCT06540066 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-03-16

No results posted yet for this study

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

Interventions

DRUG

BGB-B3227

Administered intravenously.

DRUG

Tislelizumab

Administered intravenously.

DRUG

Chemotherapy

Administered in accordance with relevant local guidelines and/or prescribing information.

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2026-01-09
Completion
2026-01-09
FDA Drug
Yes

Countries

  • United States
  • China
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06540066 on ClinicalTrials.gov