The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors
Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
Summary
Dose-escalation study will be conducted in patients with locally advanced/metastatic solid
tumors who have failed standard treatment, or cannot tolerate standard treatment, or have no
recommended standard treatment, or do not apply standard treatment, to evaluate the safety,
PK, tolerability and effectiveness of VC004. According to the efficacy, safety and PK of
dose-escalation study , the investigator and the sponsor jointly determine the dose for dose
extension, and evaluate the anti-tumor effect of VC004 on NTRK fusion-positive subjects, and
provide more information for RP2D.
According to the tolerability and pharmacokinetic results of dose-escalation study , an
appropriate dose or MTD will be selected, namely RP2D, to further assess anti-tumor efficacy
and safety in patients with NTRK fusion-positive locally advanced/metastatic solid tumors .
ORR will be chosen as the main efficacy indicator to evaluate the anti-tumor efficacy and
safety of VC004 .