Phase
Condition
Neoplasm Metastasis
Neoplasms
Treatment
BGB-B455
Chemotherapy
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. Onlyparticipants with CLDN6+ high-grade OC (ie, ovarian cancer, fallopian tube cancer,or primary peritoneal cancer) will be enrolled in dose escalation cohorts, startingfrom Protocol Amendment 3.0.
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 certain cohorts.
≥ 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 NSW 2148
AustraliaActive - Recruiting
Liverpool Hospital
Liverpool, New South Wales NSW 2170
AustraliaActive - Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality 100142
ChinaCompleted
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality 201321
ChinaActive - Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi 030013
ChinaActive - Recruiting
Adventhealth
Celebration, Florida 34747-4606
United StatesActive - Recruiting
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107-4307
United StatesActive - Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota 57105-2108
United StatesActive - Recruiting
Next Oncology
San Antonio, Texas 78229-6028
United StatesActive - Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-4433
United StatesActive - Recruiting

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