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Recruiting

NCT Number: NCT06658353

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

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.

Recruiting

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Key information

Conditions

Locally Advanced Solid Tumor

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Ning Li

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VC004 Capsules

Drug

VC004 Capsules BID

Primary outcomes

  1. Objective response rate(ORR)

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

xiaojuan Lai

CONTACT

[email protected]

15358160458

Sponsors and collaborators

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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