RecruitingPhase 3NCT06658353

Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic 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

Sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Enrollment

54 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Solid Tumor

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.

Eligibility

Min Age: 12 Years

Inclusion Criteria2

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 Criteria3

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.

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