RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-30
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06540066

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed locally advanced or metastatic solid tumors with a high prevalence of mucin 1(MUC1) expression
  2. * At least 1 measurable lesion per RECIST v1.1
  3. * Stable Eastern Cooperative Oncology Group Performance Status of ≤ 1
  4. * Adequate organ function
  5. * Willing to use a highly effective method of birth control
  1. * History of prior ≥ Grade 3 Cytokine Release Syndrome (CRS)
  2. * History of severe Infusion-Related Reactions (IRRs), allergic reactions, or hypersensitivity to any ingredients or components of the study treatments
  3. * Infection requiring systemic (oral or intravenous) therapy ≤ 14 days before the first dose of study drug(s), or participants with symptomatic COVID-19 infection
  4. * Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  5. * Active autoimmune disease or history of autoimmune disease(s) that may relapse

Contacts and Locations

Study Contact

Study Director
CONTACT
1.877.828.5568
clinicaltrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Next Oncology
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-30
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2024-08-30
Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

  • BGB-B3227
  • tislelizumab
  • BGB-A317
  • advanced solid tumor
  • metastatic solid tumor

Additional Relevant MeSH Terms

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