Testing WTX212A for advanced malignant tumors
A MulticenterOpen LableDose Escalat Tion and Dose Expansion Clinical Study to Evaluate the Safety, Tolerance and Ini Itial Effectiveness of WTX212A Injection in Patients with Unresectable or Metasta Atic Advanced Solid Tumors
This study is testing a new injection called WTX212A to see if it can help people with advanced tumors that haven't responded to other treatments.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06026605 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of WTX212A injection in patients with unresectable or metastatic advanced solid tumors who have not responded to previous treatments. It consists of two phases: a dose escalation phase to determine the optimal dosage and a dose expansion phase to further assess its efficacy. The study is open-label and multi-center, allowing for a diverse patient population. Participants will undergo various assessments to monitor the drug's pharmacokinetics and pharmacodynamics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with unresectable or metastatic solid tumors that have failed previous systemic therapies.
Not a fit: Patients with serious medical conditions or those who are not suitable for systemic treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.
How similar studies have performed: Other studies have shown promise with similar investigational therapies, but the specific approach of WTX212A is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Must signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures; 2. Aged 18 to 75 years old (including threshold); 3. Histopathology diagnosed unresectable or metastatic solid tumors who have failed systemic treatment or have no effective standard treatment, or who are unwilling to accept standard treatment or are not suitable for standard treatment; 4. ECOG≤1； 5. Expected life ≥ 3 months； 6. Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration; 7. Women of childbearing age must have a negative pregnancy testing results within ≤ 7 days before the first trial drug administration. Exclusion Criteria: \- 1. Other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases, 2. Pleural and ascitic fluids with clinical symptoms and the need for repeated drainage; 3. Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia; 4. History of adverse events related to the use of IO drugs that require permanent cessation of IO treatment; 5. Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years. 6\. Symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment; 7. Hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases; 8. Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment;
Where this trial is running
Hangzhou, Zhejiang
- the First Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Qi Zhang, M.D.
- Email: qi.zhang@zju.edu.cn
- Phone: 13858108798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.