This is a non-randomized, open-label, multicenter Phase I/II study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Administered intravenously
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGDLTs
Incidence of dose limiting toxicities
Time frame: 21 days after first dose
AEs
Type, incidence and severity of Adverse Events
Time frame: Up to 24 months
SAEs
Type, incidence and severity Serious Adverse Events (SAEs)
Time frame: Up to 24 months
ORR
Overall response rate assessed by the investigator according to RECIST version 1.1
Time frame: Up to 24 months
Cmax
aximum concentration (Cmax)
Time frame: Up to 24 months
Tmax
time to peak drug concentration
Time frame: Up to 24 months
AUC
Area Under the Curve
Time frame: Up to 24 months
t1/2
terminal half-life of the ADC, total antibody and free payload
Time frame: Up to 24 months
ADAs
Specification and quantification of anti-drug antibodies
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.