Phase
Condition
Neoplasms
Treatment
BGB-B455
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed advanced or metastatic, and unresectablesolid tumors who have previously received standard systemic therapy for advanced ormetastatic disease or for whom treatment is not available or not tolerated.
Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue forcentral CLDN6 testing and other biomarker assessments.
Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is requiredfor Phase 1a dose escalation Cohort 5 and higher.
≥ 1 measurable lesion as assessed by RECIST v1.1.
Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Adequate organ function.
Exclusion
Exclusion Criteria:
Prior systemic anticancer therapy, including chemotherapy, immunotherapy (eg,interleukin, interferon, thymosin), targeted therapy, and antibody drug conjugates (ADCs) that are standard or investigational agents (including herbal medicine orChinese [or other country] patent medicines, ≤ 14 days or 5 half-lives (whichever isshorter) before the first dose of study drug(s).
Palliative radiation treatment or other locoregional therapies ≤ 14 days before thefirst dose of study drug(s).
Live vaccine ≤ 28 days before the first dose of study drug(s). Vaccines for COVID-19are allowed except for any live vaccine that may become available. Seasonal vaccinesfor influenza are generally inactivated vaccines and are allowed. Intranasalvaccines are live vaccines and are not allowed.
Any major surgical procedure ≤ 28 days before the first dose of study drug(s).
History of prior ≥ Grade 3 cytokine release syndrome (CRS).
Participants with toxicities (because of prior anticancer therapy) that have notrecovered to baseline or stabilized, except for adverse events not considered alikely safety risk (eg, alopecia, neuropathy, and specific laboratoryabnormalities).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales 2148
AustraliaActive - Recruiting
Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaSite Not Available
Mater Cancer Care Centre
South Brisbane, Queensland 4101
AustraliaSite Not Available
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaSite Not Available
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi 330006
ChinaSite Not Available
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai 201321
ChinaActive - Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi 030013
ChinaSite Not Available
Adventhealth
Celebration, Florida 34747-4606
United StatesSite Not Available
Florida Cancer Specialists and Research Institute
Lake Mary, Florida 32746-2115
United StatesActive - Recruiting
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107-4307
United StatesSite Not Available
Avera Cancer Institue
Sioux Falls, South Dakota 57105-2108
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105-2108
United StatesSite Not Available
Next Oncology
San Antonio, Texas 78229-6028
United StatesActive - Recruiting
Ut Health San Antonio Mays Cancer Center
San Antonio, Texas 78229-4427
United StatesSite Not Available
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-4433
United StatesSite Not Available
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