This is a multi-center, open-label, Phase 1 clinical study of ZGGS15 for the treatment of patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
ZGGS15 for dose escalations are set as 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, and 30 mg/kg, intravenous infusion, once every 3 weeks.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The incidence of dose-limiting toxicities (DLTs)
A DLT is defined as any of the following adverse events occurring from the first dose to the end of the first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progression or definitely due to an external cause.
Time frame: Up to 21Days
The maximum tolerated dose (MTD)
During the dose-escalation stage, if ≥ 2 patients in a dose group experienced DLTs, then the dose level will be considered to be an intolerable dose, and the previous lower dose will be considered to be the MTD.
Time frame: Up to 24 Months
The recommended dose for subsequent study
The recommended dose for the subsequent study will be based on the data of preliminary efficacy, safety, PK, receptor occupancy results and biomarker (for example, immune activation), etc. from the dose-escalation phase, and will be fully evaluated among the investigators and the sponsor. The recommended dose for subsequent study should have at least 6 evaluable patients.
Time frame: Up to 24 Months
Objective Response Rate (ORR)
Disease control rate (DCR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
Time frame: Up to 24 Months
Duration of response (DOR)
Objective Response Rate will be determined from investigator derived tumor assessments per RECIST v. 1.1.
Time frame: Up to 24 Months
Disease control rate (DCR)
Disease control rate (DCR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
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Time frame: Up to 24 Months