An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous BAY 1179470 in Subjects With Advanced, Refractory Solid Tumors.
Overview
- Phase
- Phase 1
- Intervention
- BAY1179470
- Conditions
- Neoplasms
- Sponsor
- Bayer
- Enrollment
- 35
- Primary Endpoint
- Number of participants with Adverse Events as a Measure of Safety and Tolerability
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with advanced, histologically or cytologically confirmed solid tumors refractory to any standard therapy or have no standard therapy available or subjects actively refuse any treatment which would be regarded standard
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 and a life expectancy of at least 3 months
- •Adequate bone marrow, liver, and renal function.
- •For subjects in the additional cohort:
- •Subjects with advanced, histologically or cytologically confirmed gastric cancer.
- •At least moderate FGFR2 expression in the tumor tissue from archival samples is confirmed
Exclusion Criteria
- •History of severe allergic reactions to monoclonal antibody therapy
- •Uncontrolled hypertension defined as systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 90 mmHg, despite optimal medical management
- •Any condition that is unstable or could jeopardize the safety of the subject and his / her compliance in the study
Arms & Interventions
BAY1179470 (expansion)
Expansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
Intervention: BAY1179470
BAY1179470 (Dose escalation)
BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
Intervention: BAY1179470
BAY1179470 (additional)
Additional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
Intervention: BAY1179470
Outcomes
Primary Outcomes
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to 2 years
Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470
Time Frame: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
Maximum drug concentration (Cmax) and minimal drug concentration (Cmin) of BAY1179470 in plasma after single and multiple dose administration
Time Frame: Cycle 1 and 2: pre-dose, 0.5, 1 , 2, 3, 5, 8, 24, 48, 72, 168 and 336 hours after start of the infusion, Cycle 3 and 4: pre-dose and 1 hour after start of the infusion; each cycle is 21 days
Secondary Outcomes
- Immunogenicity(Cycle 1 and Cycle 2 pre-dose and every second cycle thereafter pre-dose. End of treatment visit and follow-up visit up to 2 years; each cycle is 21 days)
- Biomarker (biopsy)(Cycle 1: pre-dose and Day 8; cycle 1 is 21 days)
- Tumor response(Every 42 days)
- Biomarker (plasma)(Cycle 1: pre-dose, 24 hours after start of the infusion and Day 15, Cycle 2, 3 and 4: pre-dose; each cycle is 21 days)