To characterize the safety, tolerability, pharmacokinetics and immunogenicity of anetumab ravtansine in subjects with advanced solid cancers and with different degrees of hepatic or renal impairment
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
All subjects received anetumab ravtansine 6.5 mg/kg BW (body weight) once every three weeks
Unnamed facility
Caen, France
Unnamed facility
Dijon, France
Unnamed facility
Lille, France
Unnamed facility
Lyon, France
Unnamed facility
Number of subjects with treatment-emergent adverse events (TEAEs) and significant abnormalities in safety assessments related to anetumab ravtansine (BAY94-9343) in each of the 4 treatment groups
Time frame: After the first application of the study drug up until the safety follow up visit, i.e., 30-35 days after the last dose of the study drug.
AUC for antibody drug conjugate (ADC), total antibody (TA), derivative 4 of maytansine (DM4), and S methyl derivate of DM4 (DM4-Me) after single (first) dose administration of anetumab ravtansine (BAY94-9343) in Cycle 1
Time frame: From pre-dose until 504 hours post dose during cycle 1
AUC(0-tlast) for ADC, TA, DM4 and DM4-Me after single (first) dose administration of anetumab ravtansine (BAY94-9343) in Cycle 1
Time frame: From pre-dose until 504 hours post dose during cycle 1
Cmax for ADC, TA, DM4 and DM4-Me after single (first) dose administration of anetumab ravtansine (BAY94-9343) in Cycle 1
Time frame: From pre-dose until 504 hours post dose during cycle 1
Cmax,md for ADC, TA, DM4 and DM4-Me in Cycle 3
Time frame: From pre-dose until 504 hours post dose during cycle 3
AUC(0-tlast)md for ADC, TA, DM4 and DM4-Me in Cycle 3
Time frame: From pre-dose until 504 hours post dose during cycle 3
Number of subjects with positive immunogenicity results for anti anetumab ravtansine (BAY94-9343) antibodies (anti drug antibody [ADA])
Time frame: From pre-dose on Day1 of Cycle 1 until the safety follow-up visit, i.e., 30-35 days after the last dose of the study drug
Number of subjects with positive immunogenicity results for anetumab ravtansine (BAY94-9343) neutralizing antibody (NAB)
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Marseille, France
Unnamed facility
Saint-Herblain, France
Unnamed facility
Toulouse, France
Unnamed facility
Chisinau, Moldova
Time frame: From pre-dose on Day1 of Cycle 1 until the safety follow-up visit, i.e., 30-35 days after the last dose of the study drug