Locally Advanced Solid Tumor
Conditions
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.
Interventions
DRUGVC004 Capsules
VC004 Capsules BID
Sponsors
Jiangsu vcare pharmaceutical technology co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR) | 6 months |
Countries
China
Contacts
CONTACTxiaojuan Lai
PRINCIPAL_INVESTIGATORyuankai Shi
Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed