A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of AK137 in patients with advanced malignant tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
IV infusion, specified dose on specified days.
Shanghai Pulmonary Hospital
Shanghai, China
AEs
Incidence and severity of participants with adverse events
Time frame: From time ICF is signed until 90 days after last dose of AK137
DLT
Time frame: During the first 28-day of treatment with AK137
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Duration of Response (DoR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Progression Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Cmax of AK137
Time frame: From first dose of study drug through end of treatment (up to approximately 2 years)
Cmin of AK137
Time frame: From first dose of study drug through end of treatment (up to approximately 2 years)
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of study drug through 30 days after last dose of study drug
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