NCT04614740

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

Single-arm, Open, Multi-center Phase I/Phase II Clinical Study to Assess the Safety, Tolerability, Pharmacokinetic and Effectiveness of VC004

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Jiangsu vcare pharmaceutical technology co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Locally Advanced Solid Tumor
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	VC004	25 mg capsules,50 mg capsules,100 mg capsules.

Timeline

• Start date: 2020-11-20
• Primary completion: 2024-01-31
• Completion: 2024-06-30
• First posted: 2020-11-04
• Last updated: 2022-12-13

Locations

21 sites across 1 country: China