This is an open-label, multi-center, multi-cohort, phase Ib/II clinical trial, divided into 8 cohorts according to tumor types. Cohorts 1-4 are SYHA1813 combined with different regimens, including safety run-in stage and cohort expansion stage. Cohorts 5-8 are SYHA1813 monotherapy and only include the expansion cohorts. The primary objective was to evaluate the safety and efficacy of SYHA1813 single agent or in combination with different regimens in unresectable locally advanced or metastatic solid tumors.
In the safety run-in stage, the "3+3" design is used to evaluate the tolerability and safety of different dose levels combined with different regimens, and the observation period of DLT is set as the first treatment cycle. After 3 DLT-evaluable participants at each dose level completed the DLT observation period, the safety of the dose level is evaluated by an SMC consisting of the investigator and the sponsor's medical monitor. Cohorts 1-4 enter the cohort expansion stage after determining the SYHA1813 dose regimen during the safety run-in stage. Cohorts 5-8 enter the cohort expansion stage directly. In the expansion stage, cohorts 1-6 are single-arm studies, the primary endpoint is ORR as evaluated by investigator according to RECIST 1.1. Cohorts 7-8 are randomized controlled studies, the primary endpoint is PFS as evaluated by investigator according to RECIST 1.1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
In accordance with the protocol
In accordance with the protocol
In accordance with the protocol
In accordance with the protocol
In accordance with the protocol
In accordance with the protocol
In accordance with the protocol
In accordance with the protocol
In accordance with the protocol
DLT
Safety run-in stage,Dose-limiting toxicity (DLT) will be assessed according to NCI-CTCAE v5.0.
Time frame: Up to approximately 2years
Frequency and severity of TEAE and SAE
Safety run-in stage
Time frame: Up to approximately 2years
ORR
Cohorts 1-6, Objective response rate (ORR) as evaluated by Investigator (RECIST1.1)
Time frame: Up to approximately 2 years
PFS
Cohorts 7-8, Progression-free survival (PFS) as evaluated by Investigator (RECIST1.1)
Time frame: Up to approximately 2years
OS
Overall survival
Time frame: Up to approximately 2years
DoR
Duration of response
Time frame: Up to approximately 2years
DCR
Disease control rate
Time frame: Up to approximately 2 years
Frequency and severity of TEAE and SAE
Safety
Time frame: Up to approximately 2 years
Plasma Concentration
Concentration of SYHA1813/SG001/HB1801 in serum
Time frame: Up to approximately 2 years
Immunogenicity
Incidence of SG001 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)
Time frame: Up to approximately 2 years
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