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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Cancer
Intervention / Treatment

-

Contacts and Locations

Hackensack

Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

San Antonio

Next Oncology, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2027-01-31