This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study of AMT-562 in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Administered AMT-562 for injection intravenously
Macquarie University Hospital
North Ryde, New South Wales, Australia
RECRUITINGCabrini Malvern Hospital
Malvern, Victoria, Australia
RECRUITINGDLTs
Incidence of dose limiting toxicities
Time frame: up to 24 month
AEs
Type, incidence and severity of Adverse Events
Time frame: up to 24 month
SAEs
Type, incidence and severity Serious Adverse Events (SAEs)
Time frame: up to 24 month
Cmax
Maximum concentration (Cmax)
Time frame: up to 24 month
Tmax
time to peak drug concentration
Time frame: up to 24 month
AUC
Area Under the Curve
Time frame: up to 24 month
t1/2
terminal half-life of the ADC, total antibody and free payload
Time frame: up to 24 month
ADAs
Specification and quantification of anti-drug antibodies
Time frame: up to 24 month
ORR
Overall response rate assessed by the investigator according to RECIST version 1.1
Time frame: up to 24 month
DCR
Disease control rate assessed by the investigator according to RECIST version 1.1
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Time frame: up to 24 month
PFS
Progression-free survival assessed by the investigator according to RECIST version 1.1
Time frame: up to 24 month
TTR
Time to response assessed by the investigator according to RECIST version 1.1
Time frame: up to 24 month
DOR
Duration of response assessed by the investigator according to RECIST version 1.1
Time frame: up to 24 month