Actively Recruiting
A Phase 1, Open-Label Study Investigating the Safety, Tolerability, and Preliminary Activity of BGB-B455 in Adults With Selected Advanced or Metastatic Solid Tumors
Led by BeOne Medicines · Updated on 2026-05-22
90
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying BGB-B455, a bispecific antibody that targets the CLDN6 protein found on some advanced or metastatic solid tumors. This trial aims to find the recommended dose of BGB-B455 and understand the medical issues that participants may encounter while taking it. The study is in Phase 1 and includes participants with tumors expressing CLDN6, focusing on safety and initial effectiveness. The study has two parts: Phase 1a involves dose escalation where increasing amounts of BGB-B455 are given to groups of participants, either alone or combined with selected chemotherapy based on emerging data. Phase 1a also includes a safety expansion to further assess selected doses. Phase 1b is a dose expansion phase that enrolls participants at the best dose to evaluate the drug's impact on certain solid tumors. Participants will receive BGB-B455 doses on specific schedules, with or without chemotherapy, based on their study group. Researchers will monitor safety by tracking adverse events and serious adverse events from the first dose through about 7 months. They will measure tumor response and drug levels in the blood over up to 18 months. This open-label study involves various assessments including biomarker testing, tumor measurements, and regular follow-up to evaluate both safety and potential anti-tumor activity.
CONDITIONS
Brief Title
A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with advanced or metastatic, unresectable solid tumors
- Previously received standard systemic therapy or no available/tolerated treatment
- Agreement to provide tumor tissue for CLDN6 testing and biomarkers
- Tumors must express CLDN6 protein for certain groups
- At least one measurable tumor lesion by RECIST v1.1
- Stable performance status (ECOG 0 or 1)
- Adequate organ function
You will not qualify if you...
- Prior systemic anticancer therapy within 14 days or 5 half-lives before study drug start
- Recent palliative radiation or locoregional therapies within 14 days before study drug
- Live vaccines within 28 days before study drug; COVID-19 vaccines allowed except live types
- Major surgery within 28 days before study drug
- History of severe (Grade 3 or higher) cytokine release syndrome
- Unresolved toxicities from prior anticancer treatments except certain mild side effects
- Other protocol-specific exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month
Participants receive initial dose escalation of BGB-B455 to determine safety and recommended dose.
Multiple visits during dose escalation cohorts
Duration - Up to approximately 7 months
Participants are treated with BGB-B455 alone or in combination with investigator-selected chemotherapy at the recommended dose to assess safety and preliminary activity.
Repeated dosing visits according to protocol schedule
Duration - Up to approximately 18 months
Participants are monitored for safety and treatment response after completing treatment.
Periodic visits for assessments during follow-up
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
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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