Trial Condition(s):

Medical Oncology

Phase I, dose-escalation trial of BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)

Bayer Identifier:

16897

ClinicalTrials.gov Identifier:

NCT02368951

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

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

Trial Summary

Enrollment Goal
20
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Aprutumab Ixadotin (BAY1187982)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60611

Status
Completed
 
Locations

Investigative Site

Nashville, United States, 37232

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 03080

Status
Terminated
 
Locations

Investigative Site

Singapore, Singapore, 169610

Status
Terminated
 
Locations

Investigative Site

San Francisco, United States, 94115

Status
Terminated
 
Locations

Investigative Site

Santa Monica, United States, 90404-1200

Status
Terminated
 
Locations

Investigative Site

New Haven, United States, 06520

Status
Terminated
 
Locations

Investigative Site

St. Louis, United States, 63110

Status
Terminated
 
Locations

Investigative Site

New York, United States, 10016

Status
Terminated
 
Locations

Investigative Site

Baltimore, United States, 21231

Status
Terminated
 
Locations

Investigative Site

Seattle, United States, 98109-1023

Status
Terminated
 

Trial Design