A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AK130 (TIGIT/TGF-β bifunctional fusion protein) in patients with advanced malignant tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
IV infusion, specified dose on specified days.
The Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Incidence and severity of participants with adverse events (AEs)
Time frame: From time ICF is signed until 90 days after last dose of AK130
Number of participants with DLTs
Time frame: During the first four weeks of treatment with AK130
Objective response rate (ORR)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
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
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Maximum observed concentration (Cmax) of AK130
The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.
Time frame: From first dose of study drug through end of treatment (up to approximately 2 years)
Minimum observed concentration(Cmin) of AK130
The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.
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Time frame: From first dose of study drug through end of treatment (up to approximately 2 years)
Area under the curve (AUC) of AK130 for assessment of pharmacokinetics
The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.
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