radiotherapy: Radiotherapy will be administered sequentially, with WTX212A treatment starting within one week after the completion of radiotherapy
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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
Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy — From enrollment to the end of treatment,an average of 1 year Disease Control Rate (DCR) of WTX212A monotherapy or WTX212A in combination with radiotherapy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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