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 |
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)
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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