The study is a Phase 1, open-label, multicenter, dose escalation study to evaluate the safety, tolerability, PK and PD of ASKG315 as a single agent in patients with advanced solid tumors.
Each part of the study consists of 3 periods: screening (up to 28 days), treatment and follow-up. After an initial screening period, ASKG315 will be administered once every 3 weeks by intravenous (IV) infusion. The Part 1 dose escalation consists of 6 planned escalation cohorts, with a starting dose of 3 mg.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Injection with dose escalation stage of 3mg up to 45mg as well as dose expansion stage with recommended dose level from dose escalation stage.
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGthe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGShandong cancer hospital
Jinan, Shandong, China
RECRUITINGDose limiting toxicities (DLTs)
To evaluate the safery of ASKG315 in subjects.
Time frame: 21days
Adverse events(AEs)
To evaluate the safery of ASKG315 in subjects.
Time frame: 21days
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of ASKG315 in subjects.
Time frame: 21days
Area under the concentration time curve (AUC)
To evaluate the systemic pharmacokinetics of ASKG315 in subjects.
Time frame: 21days
Cytokine
Increase in circulating cytokine levels.
Time frame: 21days
Immunocyte
Changes in immunocyte levels by flow cytometry.
Time frame: 21days
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Shanghai East Hospital
Shanghai, Shanghai Municipality, China
RECRUITING