NCT07269899 A Phase I Study of WTX212A Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors
| NCT ID | NCT07269899 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sun Yat-sen University |
| Condition | Solid Tumor Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2025-11-25 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
RuiHua Xu, PhD
PRINCIPAL INVESTIGATOR
Cancer Center of SUN YAT-senU
Frequently Asked Questions
Who can join the NCT07269899 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumor Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07269899 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07269899 currently recruiting?
Yes, NCT07269899 is actively recruiting participants. Contact the research team at xurh@sysucc.org.cn for enrollment information.
Where is the NCT07269899 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China.
Who is sponsoring the NCT07269899 clinical trial?
NCT07269899 is sponsored by Sun Yat-sen University. The principal investigator is RuiHua Xu, PhD at Cancer Center of SUN YAT-senU. The trial plans to enroll 12 participants.
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