the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009, China
Location status: Recruiting
NCT Number: NCT06026605
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
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Request Info18 year–75 year
All sexes
Interventional
Early Phase 1
Hangzhou, Zhejiang, 310009, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
WTX212A infusion once every 21 days
Time frame: through study completion, an average of 1 year
The incidence of Adverse Events during the treatment of WTX212A injection
Time frame: through study completion, an average of 1 year
The incidence of TRAE during the treatment of WTX212A injection
Time frame: through study completion, an average of 1 year
The incidence of SAE during the treatment of WTX212A injection
Time frame: through study completion, an average of 1 months
Cmax
Time frame: through study completion, an average of 1 months
Tmax
Time frame: through study completion, an average of 1 months
AUC0-t
Time frame: through study completion, an average of 1 months
t1/2
Time frame: through study completion, an average of 1 months
CL
Time frame: through study completion, an average of 1 months
Cmin,ss
Time frame: through study completion, an average of 1 months
Cmax,ss
Time frame: through study completion, an average of 1 months
Tmax,ss
Time frame: through study completion, an average of 1 months
AUC(0-τ)ss.
Time frame: through study completion, an average of 1 year
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 4 months
According to Response Evaluation Criteria In Solid Tumors Version 1.1
Time frame: through study completion, an average of 1 year
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
The proportion of anti-drug antibodies (ADA) after WTX212A infusion
Time frame: through study completion, an average of 1 year
The absolute value of immune cell subsets
Time frame: through study completion, an average of 1 year
The percentage of immune cell subsets
Time frame: through study completion, an average of 1 year
The proportion of PD-L1 expression in tumor cells/immune cells
Contact information is provided by the study sponsor or research team.
Zhejiang University
Other
A MulticenterOpen LableDose Escalat Tion and Dose Expansion Clinical Study to Evaluate the Safety, Tolerance and Ini Itial Effectiveness of WTX212A Injection in Patients with Unresectable or Metasta Atic Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.