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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Locally Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VC004 Capsules

Group Type EXPERIMENTAL

VC004 Capsules

Intervention Type DRUG

VC004 Capsules BID

Interventions

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VC004 Capsules

VC004 Capsules BID

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No