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Trial Title:
A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors
NCT ID:
NCT06540066
Condition:
Advanced Cancer
Advanced Solid Tumor
Metastatic Cancer
Metastatic Solid Tumor
Conditions: Official terms:
Neoplasms
Tislelizumab
Conditions: Keywords:
BGB-B3227
tislelizumab
BGB-A317
advanced solid tumor
metastatic solid tumor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BGB-B3227
Description:
Administered intravenously.
Arm group label:
Phase 1a Part A: Dose Escalation (BGB-B3227 Monotherapy)
Arm group label:
Phase 1a Part B: Dose Escalation (BGB-B3227 + tislelizumab)
Arm group label:
Phase 1b: Dose Expansion
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Administered intravenously.
Arm group label:
Phase 1a Part B: Dose Escalation (BGB-B3227 + tislelizumab)
Arm group label:
Phase 1b: Dose Expansion
Other name:
BGB-A317
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Administered in accordance with relevant local guidelines and/or prescribing information.
Arm group label:
Phase 1b: Dose Expansion
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.
Criteria for eligibility:
Criteria:
Inclusion 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
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Facility:
Name:
Next Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Start date:
August 30, 2024
Completion date:
January 31, 2027
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06540066
