WTX212A alone or combined with radiotherapy for 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

This study will test whether WTX212A, given alone or together with radiotherapy, can help people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT07269899 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed advanced solid tumors who can give informed consent and meet the study's health criteria.

Not a fit: Patients with uncontrolled serious internal diseases, severe cardiovascular conditions, recurrent or untreated effusions, or other exclusionary medical issues may not receive benefit from the study drug.

Why it matters

Potential benefit: If successful, WTX212A could offer a new treatment option that shrinks tumors or prolongs disease control, potentially more so when combined with radiotherapy.

How similar studies have performed: Combining systemic biologics or immunotherapies with radiotherapy has shown promising signals in early trials, but WTX212A's safety and activity in this setting remain preliminary and unproven.

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.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• 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

Conditions: Solid Tumor Cancer, Cancer