Neoplasms
Conditions
Keywords
Phase I, Dose escalation, Advanced, refractory solid tumors, FGFR2
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
Interventions
DRUGBAY1179470
BAY1179470 will be administered as a 1-hour intravenous infusion.
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | Every 42 days | Tumor response will be evaluated based on the RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria. |
| 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 |
| 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 |
Countries
Japan, Singapore, South Korea
Outcome results
None listed