Actively Recruiting
A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
Led by BeiGene · Updated on 2026-04-15
90
Participants Needed
13
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors. The main questions it aims to answer are: * What is the recommended dosing for BGB-B455? * What medical problems do participants have when taking BGB-B455? The study has two parts: * Phase 1a: dose escalation and safety expansion * Phase 1b: dose expansion
CONDITIONS
Official Title
A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced or metastatic, unresectable solid tumors
- Previous treatment with standard systemic therapy for advanced/metastatic disease or no available/tolerated treatment
- Agreement to provide tumor tissue for central CLDN6 testing and biomarker assessments
- Tumor must express CLDN6 protein for certain study groups
- At least one measurable tumor lesion as per RECIST v1.1 criteria
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function
You will not qualify if you...
- Prior systemic anticancer therapy within 14 days or 5 half-lives before first study drug dose
- Palliative radiation or local therapies within 14 days before first study drug dose
- Receipt of live vaccine within 28 days before first study drug dose (except COVID-19 vaccines)
- Major surgery within 28 days before first study drug dose
- History of severe (Grade 3 or higher) cytokine release syndrome
- Unresolved toxicities from prior anticancer therapy except certain non-safety risks (e.g., hair loss, neuropathy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Adventhealth
Celebration, Florida, United States, 34747-4606
Actively Recruiting
2
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107-4307
Actively Recruiting
3
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105-2108
Actively Recruiting
4
Next Oncology
San Antonio, Texas, United States, 78229-6028
Actively Recruiting
5
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-4433
Actively Recruiting
6
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia, NSW 2148
Actively Recruiting
7
Liverpool Hospital
Liverpool, New South Wales, Australia, NSW 2170
Actively Recruiting
8
Mater Cancer Care Centre
South Brisbane, Queensland, Australia, QLD 4101
Actively Recruiting
9
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Completed
10
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
11
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China, 330006
Actively Recruiting
12
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
13
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 030013
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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