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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorJiangsu vcare pharmaceutical technology co., LTD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • VC004 Capsules

    Drug

    VC004 Capsules BID

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: VC004 CapsulesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate(ORR)

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.