NCT06658353

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
8mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

October 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

March 17, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

October 24, 2024

Last Update Submit

March 18, 2025

Conditions

Locally Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Objective response rate(ORR)

    6 months

Study Arms (1)

VC004 Capsules

EXPERIMENTAL
Drug: VC004 Capsules

Interventions

VC004 CapsulesDRUG

VC004 Capsules BID

VC004 Capsules

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

  • yuankai Shi

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaojuan Lai

CONTACT

15358160458lai_xiaojuan@vcarepharmatech.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 26, 2024

Study Start

March 17, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations

CN(1)