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

Jiangsu Vcare PharmaTech

Status and phase: Enrolling; Phase 3

Conditions: Locally Advanced Solid Tumor

Treatments: Drug: VC004 Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT06658353

VC004-301

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

VC004 Capsules

Experimental group

Treatment:

Drug: VC004 Capsules