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.
Fully understand the study and voluntarily sign the informed consent form.
Male or female 18-70 years of age;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
Life expectancy ≥ 3 months.
Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
Sequential
ZG005 Powder for Injection
Drugintravenous infusion(IV), once every 3 weeks
Donafenib Tosilate Tablets
DrugThe 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
Objective 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.
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
Duration of response (DOR)
Time from the first evaluated CR or PR until PD or death from any cause
Click on the lead sponsor to view all of their trials.
