This trial is a multi-center, open-label investigator-initiated clinical study (IIT) to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy. The study was divided into two phases: dose escalation and dose expansion
The study was divided into two phases: dose escalation and dose expansion Detailed Description: This trial is a multi-center, open-label investigator-initiated clinical study(llT)to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
WTX212A infusion once every 21 days
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGincidence of adverse events
The incidence of Adverse Events during the treatment of WTX212A injection
Time frame: through study completion, an average of 1 year
incidence of treatment related adverse events (TRAE)
The incidence of TRAE during the treatment of WTX212A injection
Time frame: through study completion, an average of 1 year
incidence of severe adverse events (SAE)
The incidence of SAE during the treatment of WTX212A injection
Time frame: through study completion, an average of 1 year
Cmax
Cmax
Time frame: through study completion, an average of 1 months
Tmax
Tmax
Time frame: through study completion, an average of 1 months
AUC0-t
AUC0-t
Time frame: through study completion, an average of 1 months
t1/2
t1/2
Time frame: through study completion, an average of 1 months
CL
CL
Time frame: through study completion, an average of 1 months
Cmin,ss
Cmin,ss
Time frame: through study completion, an average of 1 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cmax,ss
Cmax,ss
Time frame: through study completion, an average of 1 months
Tmax,ss
Tmax,ss
Time frame: through study completion, an average of 1 months
AUC(0-τ)ss.
AUC(0-τ)ss.
Time frame: through study completion, an average of 1 months
the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells
the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after WTX212A infusion
Time frame: through study completion, an average of 1 year
Objecive Response Rate (ORR)
According to Response Evaluation Criteria In Solid Tumors Version 1.1
Time frame: through study completion, an average of 4 months
Anti-drug antibody (ADA)
escribe the number and percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA
Time frame: through study completion, an average of 1 year