The study is a dose-escalation and dose-expansion study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent or in combination with standard of care (SOC) in patients with selected types of advanced solid tumors.
Monotherapy: A dose-escalation (Part A) and expansion (Part B) study of ASKG915 monotherapy was initiated to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with advanced solid tumors. Combination therapy: A dose-optimization (Part C) srudy of ASKG915 in combination with standard of care (SOC) in patients was conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with selected types of advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
594
ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.
Paclitaxel is administered intravenously at a dose of 80 mg/m², once weekly on a 21-day cycle. Bevacizumab is administered intravenously at dose of 15mg/kg, once every 3 weeks on a 21-day cycle.
The recommended dose of Fruquintinib is 5 mg orally once daily, with or without food for the first 21 days of each 28-day cycle.
Columbia University Irving Medical Center
New York, New York, United States
RECRUITINGUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITINGPeking University Cancer Hospital
Beijing, Beijing Municipality, China
Dose limiting toxicities (DLTs)
To evaluate the safery of ASKG915 in subjects.
Time frame: 21days or 28 days
Adverse events(AEs)
To evaluate the safery of ASKG915 in subjects.
Time frame: From the first dose to 30 days after the last dose
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Time frame: Until treatment discontinuation or for a maximum of 2 years
Area under the concentration time curve (AUC)
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Time frame: Until treatment discontinuation or for a maximum of 2 years
Plasma clearance rate (CL)
To evaluate the systemic pharmacokinetics of ASKG915 in subjects.
Time frame: Until treatment discontinuation or for a maximum of 2 years
Evaluation of immunogenicity
Incidence of anti-drug antibodies (ADA)
Time frame: Until treatment discontinuation or for a maximum of 2 years
Objective Response Rate (ORR)
The percentage of patients having a best overall response of complete response (CR) or partial response (PR)
Time frame: Until disease progression or for a maximum of 2 years
Duration of response (DOR)
The DOR will be calculated from the time of initial response (PR or better that is subsequently confirmed) to progression (after PR) or death
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Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGTime frame: Until disease progression or for a maximum of 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of first dose of study treatment until the date of progressive disease or death, whichever is earlier
Time frame: Until disease progression or for a maximum of 2 years