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Recruiting NCT06658353

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

Phase III Interventional Locally Advanced Solid Tumor

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VC004 Capsules.
Who it may be relevant to
Registry conditions: Locally Advanced Solid Tumor. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug VC004 Capsules
    VC004 Capsules BID

Primary outcome measures

  • Objective response rate(ORR) [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing

Identifiers

NCT: NCT06658353 · VC004-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗