Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:7/16/2016
Start Date:March 2015
End Date:June 2017

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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)


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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