This is an open-label, single-arm study with dose-escalation and expansion phases to access ATG-008 combined with Toripalimab in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Tablet
IV infusion
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGWest China of Sichuan University
Chengdu, Sichuan, China
RECRUITINGMTD
Maximum Tolerated Dose
Time frame: Within 21 days after dosing
RP2D
Recommended phase 2 dose
Time frame: Within 21 days after dosing
ORR
Overall Response Rate
Time frame: Through study completion (approximately 2 years)
Cmax
Peak Plasma Concentration (Cmax)
Time frame: Day 1 - Day 15
AUC
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 - Day 15
DOR
Duration from the first observation of at least PR to time of disease progression, or deaths due to disease progression, whichever occurs first.
Time frame: 12 months
DCR
Disease Control Rate (DCR=CBR+Stable Disease\[SD; for a minimum of 12 weeks\])
Time frame: 12 months
PFS
Duration from start of study treatment to PD or death (regardless of cause), whichever comes first
Time frame: 12 months
OS
The estimates of Kaplan-Meier
Time frame: 12 months
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