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

Phase 3

Not yet recruiting

• Conditions: Locally Advanced Solid Tumor
• Interventions: Drug: VC004 Capsules

• Registration Number: NCT06658353
• Lead Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Study Start: 2024-11-20
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

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;

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VC004 Capsules	VC004 Capsules	-

Primary Outcome Measures

Name	Time	Method
Objective response rate(ORR)	6 months

Trial Locations

Locations (1)

Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China