Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT02368951
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02368951
Study Brief:
Protocol Section:
NCT02368951