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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37232 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 169610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Francisco, United States, 94115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santa Monica, United States, 90404-1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Haven, United States, 06520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baltimore, United States, 21231 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98109-1023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
An open-label,Phase I, dose-escalation trial to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetic, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express FGFR2.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Maximum tolerated dose(MTD)The MTD is defined as the maximum dose at which the incidence of DLTs during Cycle 1 is below 20%, or the maximum dose administered, whichever is achieved first during dose escalationTimeframe: Up to 2 years
- Number of subjects with adverse events as a measure of safety and tolerabilityTimeframe: Up to 2 years
- Number of subjects with serious adverse events as a measure of safety and tolerabilityTimeframe: Up to 2 years
Secondary Outcome
- Cmax (maximum observed drug concentration in measured matrix after single dose administration)Timeframe: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
- AUC(0-tlast) AUC from time 0 to the last data point >LLOQTimeframe: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
- AUC)0-504 (AUC from zero to 504 hours post infusion)Timeframe: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
- AUC (area under the concentration vs. time curve from zero to infinity after single (first)Timeframe: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
- Cmax,md (maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval)Timeframe: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
- AUC(0-tlast)md (AUC from time 0 to the last data point >LLOQ after multiple dosing)Timeframe: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
- AUC(0-504)mdTimeframe: Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose.Cycle 5 Day 1 and every odd cycles after: pre-dose and end of infusion
- FGFR2 levels in tumor tissue sampleTimeframe: Screening
- CK18 levels in tumor tissue sampleTimeframe: Screening, Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose and end of infusion.
- Nucleosome level in plasmaTimeframe: Screening, Cycles 1 and 3, Day 1: pre-dose, end of infusion, Day 2, Day 3, Day 5, Day 8, and Day 15.Cycles 2 and 4: Day 1: pre-dose and end of infusion.
- Development of anti-drug antibodies (ADAs) in plasma as an indicator of immunogenicityTimeframe: Cycle 1: Day 1: before infusion (pre-dose), Day 8
- Tumor responseTimeframe: Screening, Day 15 (± 7 days) of Cycle 2 and every even subsequent Cycle (i.e. Cycles 2, 4, 6, 8, etc.)
Additional Information
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