First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors
Phase 1
Completed
- Conditions
- Neoplasms
- Interventions
- Drug: BAY1179470
- Registration Number
- NCT01881217
- Lead Sponsor
- Bayer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BAY1179470 (additional) BAY1179470 Additional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days. BAY1179470 (expansion) BAY1179470 Expansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days. BAY1179470 (Dose escalation) BAY1179470 BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events as a Measure of Safety and Tolerability Up to 2 years Maximum drug concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY1179470 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 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 Outcome Measures
Name Time Method 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 Analyzed for anti-BAY 1179470 antibodies
Tumor response Every 42 days Tumor response will be evaluated based on the RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria.
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 Biomarker (biopsy) Cycle 1: pre-dose and Day 8; cycle 1 is 21 days Additional cohort only