This is a single-arm, open-label, investigator-initiated clinical study (IIT) designed to evaluate the preliminary efficacy, safety, tolerability, immunogenicity, and pharmacokinetic (PK) characteristics of WTX212A Injection in patients with advanced solid tumors.
This is a single-arm, open-label, investigator-initiated clinical study (IIT) designed to evaluate the preliminary efficacy, safety, tolerability, immunogenicity, and pharmacokinetic (PK) characteristics of WTX212A Injection in patients with advanced solid tumors. The study is divided into two phases: an initial exploratory phase and an expansion phase. The study includes two cohorts: Cohort A (WTX212A monotherapy) and Cohort B (WTX212A in combination with radiotherapy)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Erythrocyte-αPD-1 Antibody Conjugates
Radiotherapy will be administered sequentially, with WTX212A treatment starting within one week after the completion of radiotherapy
Cancer Center of SUN YAT-senU
Guangzhou, Guangdong, China
RECRUITINGCancer center of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGEfficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy
Objective Response Rate (ORR) of WTX212A monotherapy or WTX212A in combination with radiotherapy
Time frame: From enrollment to the end of treatment,an average of 1 year
Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy
Disease Control Rate (DCR) of WTX212A monotherapy or WTX212A in combination with radiotherapy
Time frame: From enrollment to the end of treatment,an average of 1 year
Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy
Progression-Free Survival (PFS).etc of WTX212A monotherapy or WTX212A in combination with radiotherapy, as evaluated using the Evaluation Criteria in Solid Tumors (Version 1.1).
Time frame: Every 6 weeks until the end of the last treatment ,an average of 1 year
Safety of WTX212A monotherapy or WTX212A in combination with radiotherapy
Incidence of adverse events (AEs), treatment-related AEs, and serious adverse events (SAEs) of WTX212A monotherapy or WTX212A in combination with radiotherapy.
Time frame: From the first treatment to the end of the safety visit,an average of 1 year
Pharmacokinetic characteristics(Cmax)
Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to Cmax
Time frame: Through study completion, an average of 1 year
Pharmacokinetic characteristics(Tmax)
Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to Tmax
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Time frame: Through study completion, an average of 1 year
Pharmacokinetic characteristics(AUC0-t)
Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to AUC0-t
Time frame: Through study completion, an average of 1 year
Pharmacokinetic characteristics(t1/2)
Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to t1/2
Time frame: Through study completion, an average of 1 year
Pharmacokinetic characteristics(CL)
Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to CL
Time frame: Through study completion, an average of 1 year
Number of Anti-drug antibody (ADA)
Describe the number 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
Percentage of Anti-drug antibody (ADA)
Describe the 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