Evaluating VC004 for patients with advanced solid tumors
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
PHASE3 · Jiangsu vcare pharmaceutical technology co., LTD · NCT06658353
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 | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Jiangsu vcare pharmaceutical technology co., LTD (industry) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06658353 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are male and female patients aged 12 years and older with locally advanced or metastatic solid tumors.
Not a fit: Patients who have undergone major surgery recently or have unresolved adverse reactions from previous treatments may not benefit from this study.
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 performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating advanced solid tumors with novel therapies.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
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.
Conditions: Locally Advanced Solid Tumor