Solid Tumor Cancer, Cancer
Conditions
Keywords
Solid Tumor Cancer, Cancer
Brief summary
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.
Detailed description
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)
Interventions
Erythrocyte-αPD-1 Antibody Conjugates
RADIATIONradiotherapy
Radiotherapy will be administered sequentially, with WTX212A treatment starting within one week after the completion of radiotherapy
Sponsors
Westlake Therapeutics
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No Masking
Intervention model description
Number of Cohort : 2
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily signed informed consent, understanding of the study, and willingness and ability to complete all study procedures. 2. Male or female, aged 18 to 75 years (inclusive). 3. Patients with histologically and/or cytologically confirmed advanced malignant tumors.
Exclusion criteria
1. Suffering from other serious internal diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, liver cirrhosis, active bleeding, etc., those with uncontrollable or severe cardiovascular diseases, such as NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction, etc., within 6 months before the first dose, difficult to control hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥100mmHg). 2. Uncontrollable pleural effusion, peritoneal effusion, or pericardial effusion requiring puncture and drainage, or recurrence requiring re-drainage after puncture and drainage. 3. History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe lung function impairment. 4. Previous IO drug treatment with adverse events related to the drug that required permanent discontinuation of IO treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy | From enrollment to the end of treatment，an average of 1 year | Objective Response Rate (ORR) of WTX212A monotherapy or WTX212A in combination with radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy | Every 6 weeks until the end of the last treatment ，an average of 1 year | 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). |
| Safety of WTX212A monotherapy or WTX212A in combination with radiotherapy | From the first treatment to the end of the safety visit，an average of 1 year | Incidence of adverse events (AEs), treatment-related AEs, and serious adverse events (SAEs) of WTX212A monotherapy or WTX212A in combination with radiotherapy. |
| Pharmacokinetic characteristics(Cmax) | Through study completion, an average of 1 year | Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to Cmax |
| Pharmacokinetic characteristics(Tmax) | Through study completion, an average of 1 year | Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to Tmax |
| Pharmacokinetic characteristics(AUC0-t) | Through study completion, an average of 1 year | Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to AUC0-t |
| Number of Anti-drug antibody (ADA) | Through study completion, an average of 1 year | Describe the number of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA. |
| Percentage of Anti-drug antibody (ADA) | Through study completion, an average of 1 year | Describe the percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA. |
| Pharmacokinetic characteristics(t1/2) | Through study completion, an average of 1 year | Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to t1/2 |
| Pharmacokinetic characteristics(CL) | Through study completion, an average of 1 year | Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to CL |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assess Biomarkers Relevant to the Study（T-Cell) | Through study completion, an average of 1 year | Assess the percentages of immune cell subsets (T-Cell ) before and after treatment for advanced malignant tumors, changes in immunophenotyping and other meaningful Biomarkers |
| Assess Biomarkers Relevant to the Study（MDSC) | Through study completion, an average of 1 year | Assess the percentages of MDSC before and after treatment for advanced malignant tumors, changes in immunophenotyping and other meaningful Biomarkers |
Countries
China
Contacts
Primary ContactRuiHua Xu, PhD
Backup ContactHuiyan Luo, PhD
Outcome results
None listed