WTX212A alone or combined with radiotherapy for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm, open-label Phase I investigator-initiated study tests WTX212A monotherapy (Cohort A) and WTX212A plus radiotherapy (Cohort B) in adults with advanced solid tumors. The trial includes an initial exploratory phase followed by an expansion phase to refine dosing and gather additional evidence of activity. Key outcomes are preliminary antitumor activity, safety, tolerability, immunogenicity, and pharmacokinetics. The study is run at the Cancer Center of Sun Yat-sen University in Guangzhou in collaboration with Westlake Therapeutics.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer Center of SUN YAT-senU
  Guangzhou, Guangdong, China Recruiting
• Cancer center of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: RuiHua Xu, PhD — Cancer Center of SUN YAT-senU
• Study coordinator: RuiHua Xu, PhD
• Email: xurh@sysucc.org.cn
• Phone: 020-87343468

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.