Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 12 and up

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

PhasePhase 3
Study typeInterventional
Ages12 Years and up
SexAll
Enrollment54 (estimated)
SponsorJiangsu vcare pharmaceutical technology co., LTD
Industry-sponsored
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedMarch 17, 2025
Main results expectedDecember 30, 2026
Study endsDecember 30, 2026
Registry record updatedJuly 27, 2026
Trial IDNCT06658353 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.