Medical Oncology Clinical Trial
Official title:
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.
Verified date | July 2017 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Terminated |
Enrollment | 20 |
Est. completion date | July 27, 2016 |
Est. primary completion date | July 27, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States, Korea, Republic of, Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 escalation | Up to 2 years | |
Primary | Number of subjects with adverse events as a measure of safety and tolerability | Up to 2 years | ||
Primary | Number of subjects with serious adverse events as a measure of safety and tolerability | Up to 2 years | ||
Secondary | Cmax (maximum observed drug concentration in measured matrix after single dose administration) | 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 | ||
Secondary | AUC(0-tlast) AUC from time 0 to the last data point >LLOQ | 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 | ||
Secondary | AUC)0-504 (AUC from zero to 504 hours post infusion) | 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 | ||
Secondary | AUC (area under the concentration vs. time curve from zero to infinity after single (first) | 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 | ||
Secondary | Cmax,md (maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval) | 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 | ||
Secondary | AUC(0-tlast)md (AUC from time 0 to the last data point >LLOQ after multiple dosing) | 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 | ||
Secondary | AUC(0-504)md | 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 | ||
Secondary | FGFR2 levels in tumor tissue sample | Screening | ||
Secondary | CK18 levels in tumor tissue sample | 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. | ||
Secondary | Nucleosome level in plasma | 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. | ||
Secondary | Development of anti-drug antibodies (ADAs) in plasma as an indicator of immunogenicity | Cycle 1: Day 1: before infusion (pre-dose), Day 8 | ||
Secondary | Tumor response | Screening, Day 15 (± 7 days) of Cycle 2 and every even subsequent Cycle (i.e. Cycles 2, 4, 6, 8, etc.) |
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