Actively Recruiting
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
Led by Sun Yat-sen University · Updated on 2025-12-08
12
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
W
Westlake Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary effects, safety, immune response, and how the body processes a drug called WTX212A Injection in adults with advanced solid tumors. This single-arm, open-label study includes patients with confirmed advanced malignant tumors and aims to understand how WTX212A works alone or combined with radiotherapy. The study is investigator-initiated and focuses on early-phase results to guide future research. The study has two groups: one receiving only WTX212A and another receiving WTX212A along with radiotherapy. Radiotherapy is given first, followed by WTX212A starting within a week after radiotherapy ends. The study includes an initial exploratory phase and then an expansion phase to further assess treatments. Participants receive the study drug and may undergo radiotherapy as part of their treatment. Participants will be followed for about one year on average, with regular assessments every six weeks during treatment. Researchers will monitor how well the treatments work, measure safety and side effects, and study the drug’s behavior in the body, including immune responses. The study includes laboratory tests and clinical evaluations to gather detailed information throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
A Phase I Study of WTX212A Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent and are able to complete all study procedures
- Male or female aged 18 to 75 years inclusive
- Diagnosed with histologically or cytologically confirmed advanced malignant tumors
You will not qualify if you...
- Have serious uncontrolled internal diseases such as uncontrolled diabetes, active peptic ulcer, liver cirrhosis, or active bleeding
- Have severe cardiovascular conditions like NYHA Class II or higher heart failure, unstable angina, or recent myocardial infarction within 6 months
- Have uncontrollable pleural, peritoneal, or pericardial effusions requiring drainage or with recurrence after drainage
- Have a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe lung function impairment
- Previously stopped immune-oncology drug treatment due to serious adverse events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year
Participants receive WTX212A injection either as monotherapy or in combination with radiotherapy. Radiotherapy is given first, followed by WTX212A treatment starting within one week after radiotherapy ends.
Visits every 6 weeks during treatment
Duration - Up to 1 year after treatment ends
Participants are monitored for safety, pharmacokinetics, and immunogenicity after treatment completion.
Scheduled safety visits during follow-up
Trial Site Locations
Total: 2 locations
1
Cancer Center of SUN YAT-senU
Guangzhou, Guangdong, China, 510000
Actively Recruiting
2
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
R
RuiHua Xu, PhD
H
Huiyan Luo, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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