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Trial Title:
Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors
NCT ID:
NCT06658353
Condition:
Locally Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
VC004 Capsules
Description:
VC004 Capsules BID
Arm group label:
VC004 Capsules
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.
Criteria for 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.
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Country:
China
Contact:
Last name:
Ning Li
Start date:
November 20, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Jiangsu vcare pharmaceutical technology co., LTD
Agency class:
Industry
Source:
Jiangsu vcare pharmaceutical technology co., LTD
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06658353
