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

Launched by JIANGSU VCARE PHARMACEUTICAL TECHNOLOGY CO., LTD · Oct 24, 2024

Keywords

ClinConnect Summary

This clinical trial, called a Phase III study, is looking at a new treatment called VC004 for patients with locally advanced or metastatic solid tumors, which are types of cancers that have spread or are hard to treat. The goal of the study is to see if VC004 is safe and effective in helping these patients. The trial is currently recruiting participants who are at least 12 years old, and both males and females are welcome to join. To participate, individuals must be able to sign a consent form agreeing to take part in the study and must not have had major surgery too recently or still be recovering from side effects of previous treatments.

If someone is eligible and decides to participate, they can expect to receive VC004 as part of the study and will be monitored closely throughout the trial. This means health professionals will check on their well-being and how the treatment is affecting them. It's important to note that participants cannot have had recent strong medications that could interfere with the study drug. Overall, this trial aims to find better treatment options for patients facing challenging cancer situations.

Gender

ALL

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.