This is a Multi-center, Open-labe, Phase I/II Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
intravenous infusion(IV), once every 3 weeks
The dose groups of Donafenib for dose-exploration stage are set as 0.2g BID, 0.1g BID, and 0.1g QD, oral administration.The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage
The Second Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGObjective Response Rate (ORR)
The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.
Time frame: Up to 2 years
Dose Limiting Toxicity (DLT)
A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause
Time frame: Up to 2 years
Duration of response (DOR)
Time from the first evaluated CR or PR until PD or death from any cause
Time frame: Up to 2 years
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