Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors
Phase 3
Not yet recruiting
- Conditions
- Locally Advanced Solid Tumor
- Interventions
- Drug: VC004 Capsules
- Registration Number
- NCT06658353
- Lead Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 54
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;
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VC004 Capsules VC004 Capsules -
- Primary Outcome Measures
Name Time Method Objective response rate(ORR) 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
🇨🇳Beijing, Beijing, China