Breast Cancer Clinical Trial
Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)
Summary
To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)
Eligibility Criteria
Inclusion Criteria:
All subjects must be >/= 18 years at the first screening examination / visit
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Subjects with advanced, histologically or cytologically confirmed solid tumors described to express fibroblast growth factor receptor 2 (FGFR2) that are refractory to any standard therapy
For maximum tolerated dose (MTD) Dose Expansion: Subjects with advanced, histologically or cytologically confirmed triple-negative breast cancer who had undergone within 4 lines of systemic anti-cancer treatment and not eligible for standard therapy anymore.
Subjects need to have evaluable disease (measurable or not measurable).
Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment
Exclusion Criteria:
History of allergic reactions to monoclonal antibody therapy (or excipients in the formulation)
Anti-cancer chemotherapy, experimental cancer therapy including clinical trial, or cancer immunotherapy within 4 weeks prior to the first dose of the investigational drug.
Toxic effects of previous anti-cancer chemotherapy, experimental cancer therapy, or cancer immunotherapy have not normalized.
History of symptomatic metastatic brain or meningeal tumors unless the subject is longer than 3 months from the end of definitive therapy before the first dose of the investigational drug and has clinically or radiologically no evidence of tumor growth.
History of clinically significant cardiac disease
Congenital coagulation abnormalities
Subjects who are pregnant or are breast-feeding
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There are 13 Locations for this study
San Francisco California, 94115, United States
Santa Monica California, 90404, United States
New Haven Connecticut, 06520, United States
Chicago Illinois, 60611, United States
Baltimore Maryland, 21231, United States
Saint Louis Missouri, 63110, United States
New York New York, 10016, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Seoul , 03080, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Singapore , 16961, Singapore
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