Phase
Condition
Neoplasms
Treatment
BGB-C354
Tislelizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able to provide a signed and dated written informed consent prior to anystudy-specific procedures, sampling, or data collection.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Participants with histologically or cytologically confirmed advanced, metastatic, orunresectable solid tumors, whose cancer is not amenable to therapy with curativeintent:
≥ 1 measurable lesion per RECIST v1.1.
Able to provide an archived tumor tissue sample.
Adequate organ function.
Females of childbearing potential must be willing to use a highly effective method ≥ 7 months after the lastdose of study drug(s).
Nonsterile males must be willing to use a highly effective method of birth controlfor the duration of the study treatment period and for ≥ 4 months after the lastdose of study drug(s).
Exclusion
Exclusion Criteria:
Prior treatment with B7H3-targeted therapy.
For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) withtopoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified forspecific cohorts).
Participants with spinal cord compressions, active leptomeningeal disease oruncontrolled, or untreated brain metastasis
Any malignancy ≤ 2 years before the first dose of study treatment(s) except for thespecific cancer under investigation in this study and any locally recurring cancerthat has been treated with curative intent (eg, resected basal or squamous cell skincancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygensaturation at rest < 92%, or requirement for supplemental oxygen at baseline
Uncontrolled diabetes, or > Grade 1 laboratory test abnormalities in potassium,sodium, or corrected calcium levels despite standard medical management ≤ 14 daysbefore the first dose of study drug(s).
Infection (including tuberculosis infection) requiring systemic (oral orintravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before thefirst dose of study treatment(s).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
Westmead Hospital
Westmead 2143973, New South Wales 2155400 NSW 2145
AustraliaActive - Recruiting
St Vincents Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaSite Not Available
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
St Vincents Hospital Melbourne
Fitzroy 2166584, Victoria 2145234 VIC 3065
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne 2158177, Victoria 2145234 VIC 3004
AustraliaActive - Recruiting
One Clinical Research
Nedlands, Western Australia 6009
AustraliaSite Not Available
One Clinical Research
Nedlands 2064874, Western Australia 2058645 WA 6009
AustraliaActive - Recruiting
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaSite Not Available
Beijing Cancer Hospital
Beijing 1816670, Beijing Municipality 2038349 100142
ChinaActive - Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi 530021
ChinaSite Not Available
Guangxi Medical University Cancer Hospital
Nanning 1799869, Guangxi 1809867 530021
ChinaSite Not Available
Hubei Cancer Hospital
Wuhan, Hubei 430079
ChinaSite Not Available
Hubei Cancer Hospital
Wuhan 1791247, Hubei 1806949 430079
ChinaActive - Recruiting
Jilin Cancer Hospital
Changchun, Jilin 130021
ChinaSite Not Available
Jilin Cancer Hospital
Changchun 2038180, Jilin 2036500 130021
ChinaActive - Recruiting
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning 110042
ChinaSite Not Available
Liaoning Cancer Hospital and Institute
Shenyang 2034937, Liaoning 2036115 110042
ChinaActive - Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu 1815286, Sichuan 1794299 610041
ChinaActive - Recruiting
Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida 32827-7400
United StatesSite Not Available
Florida Cancer Specialist Research Institute Lake Nona
Orlando 4167147, Florida 4155751 32827-7400
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215-5418
United StatesSite Not Available
Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215-5418
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110-1010
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110-1010
United StatesActive - Recruiting
The University of Texas Md Anderson Cancer Center
Houston, Texas 77030-4009
United StatesSite Not Available
Next Oncology
San Antonio, Texas 78229-6028
United StatesSite Not Available
Next Oncology
Austin 4671654, Texas 4736286 78758
United StatesActive - Recruiting
The University of Texas Md Anderson Cancer Center
Houston 4699066, Texas 4736286 77030-4009
United StatesActive - Recruiting

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