NCT05212987

Study of FCN-098 in Patients With Advanced Solid Tumor

A Multi-center, Open, Single-arm Phase I Dose Exploratory Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Primary Antitumor Activity of FCN-098 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Fochon Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, open, single-arm phase I dose exploratory study to evaluate the safety, tolerability, pharmacokinetic characteristics and primary antitumor activity of FCN-098 in patients with advanced solid tumors.

Detailed description

This study is a multicenter, open, single-arm Phase I clinical study. The safety, tolerance and PK characteristics of FCN-098 in patients with advanced solid tumors were determined, the MTD of oral FCN-098 was determined, and the RP2D of FCN-098 was determined, and the efficacy of FCN-098 was preliminarily evaluated.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	FCN-098	FCN-098 will be given orally in ascending doses starting at 40 mg Q12h until the maximum tolerated dose or recommended dose is reached.

Timeline

• Start date: 2021-12-31
• Primary completion: 2024-05-08
• Completion: 2024-10-12
• First posted: 2022-01-28
• Last updated: 2022-01-28

Locations

1 site across 1 country: China