A Phase I Study of WTX212A Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors
A Phase I Study Evaluating the Preliminary Efficacy and Safety of WTX212A Injection as Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors
Sun Yat-sen University
12 participants
Nov 25, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Voluntarily signed informed consent, understanding of the study, and willingness and ability to complete all study procedures.
- Male or female, aged 18 to 75 years (inclusive).
- Patients with histologically and/or cytologically confirmed advanced malignant tumors.
Exclusion Criteria4
- 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).
- Uncontrollable pleural effusion, peritoneal effusion, or pericardial effusion requiring puncture and drainage, or recurrence requiring re-drainage after puncture and drainage.
- History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe lung function impairment.
- Previous IO drug treatment with adverse events related to the drug that required permanent discontinuation of IO treatment.
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Interventions
Erythrocyte-αPD-1 Antibody Conjugates
Radiotherapy will be administered sequentially, with WTX212A treatment starting within one week after the completion of radiotherapy
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07269899