The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors

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 .

Timeline

Start

2020-11-20

Primary completion

2024-01-31

Completion

2024-06-30

Publications

• Zhou S, Zhang C, Wang G, Qian J, Huang G, Wang J, Luo S, Zhu Y, Zhang Q, Wei T, Li Y, Li Z, Zhu D, Zhao H, Fang M, Zhou S, Xu Q, Chen Y, Nan K, Cui J, Zhu X, Gong Y, Wu Y, Lai X, Shi Y. Safety, efficacy, and pharmacokinetics of eratrectinib (VC004) in solid tumors with NTRK fusions: phase 1 results from a phase 1/2 study. Exp Hematol Oncol. 2026 Jun 26. doi: 10.1186/s40164-026-00799-9. Online ahead of print.

Drugs

Indications