Evaluating VC004 for patients with advanced solid tumors
Official title: Single-arm, Open, Multi-center Phase III Clinical Study to Assess the Safety and Effectiveness of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors
Run by Jiangsu vcare pharmaceutical technology co., LTD · NCT06658353 · Data updated 2026-11-12
This study is testing a new medication called VC004 to see if it helps people with advanced solid tumors feel better and manage their condition.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Jiangsu vcare pharmaceutical technology co., LTD Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | March 17, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT06658353 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are male and female patients aged 12 years and older with locally advanced or metastatic solid tumors.
✕Probably not a fit
Patients who have undergone major surgery recently or have unresolved adverse reactions from previous treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase III clinical trial designed to assess the safety and efficacy of VC004 capsules in patients suffering from locally advanced or metastatic solid tumors. The study is a single-arm, open-label trial conducted across multiple centers, allowing for a diverse patient population. Participants will receive VC004 and will be monitored for treatment outcomes and side effects. The trial aims to provide valuable data on the effectiveness of this intervention in a challenging patient group.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors.
How similar studies have gone: While this approach is being evaluated in this specific context, similar studies have shown promise in treating advanced solid tumors with novel therapies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All subjects or legal representatives are willing and able to sign ICF approved by the ethics committee before starting any screening procedures; * Male or female, age ≥12 years old; Exclusion Criteria: * Patients have undergone major surgery within 4 weeks prior to the first dose or are expected to undergo major surgery during the trial (excluding vascular access establishment procedures, biopsy procedures); * Adverse reactions caused by previous treatment have not recovered to ≤1 grade (evaluated by the investigator); * Patients had been treated with a strong CYP3A inhibitor or inducer within 7 days prior to the first administration of the study drug.
Where it's running
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Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: yuankai Shi — Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
- Study coordinator: xiaojuan Lai
- Email: lai_xiaojuan@vcarepharmatech.com
- Phone: 15358160458
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.