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

Jiangsu vcare pharmaceutical technology co., LTD1 site in 1 country54 target enrollmentMarch 17, 2025

ConditionsLocally Advanced Solid Tumor

InterventionsVC004 Capsules

DrugsVC004 Capsules

Overview

Phase: Phase 3
Intervention: VC004 Capsules
Conditions: Locally Advanced Solid Tumor
Sponsor: Jiangsu vcare pharmaceutical technology co., LTD
Enrollment: 54
Locations: 1
Primary Endpoint: Objective response rate(ORR)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This Study is a single arm, open label, multicenter phase III clinical trial to evaluate the safety and efficacy of VC004 in patients with locally advanced/metastatic solid tumors.

Registry

clinicaltrials.gov

Start Date

March 17, 2025

End Date

December 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Responsible Party

Sponsor

Eligibility 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.