NCT04687423

Study of FCN-011 in Patients With Advanced Solid Tumor（Phase I）and NTRK Fusion Positive Advanced Solid Tumor （Phase II）

A Multicenter, Open, Single-arm Phase I Dose Exploration and Phase II Extended Study Was Conducted to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Antitumor Activity of FCN-011 in Patients With Advanced Solid Tumor (Phase I) and NTRK Fusion Positive Advanced Solid Tumor (Phase II)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Fochon Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, open, single-arm phase I dose exploration and phase II extended study was conducted to evaluate the safety, tolerability, pharmacokinetic characteristics, and primary antitumor activity of FCN-011 in patients with advanced solid tumor (phase I) and NTRK fusion positive advanced solid tumor (phase II)

Detailed description

This study is a multicenter, open, single-arm Phase I/II clinical study, which is divided into two research parts, namely phase I dose exploration study and phase II dose extension study. In the phase I dose exploration study, the safety, tolerance and PK characteristics of FCN-011 in patients with advanced solid tumors were determined, the MTD of oral fCN-011 was determined, and the RP2D of FCN-011 in the phase II clinical study was determined, and the efficacy of FCN-011 was preliminarily evaluated. The phase II dose extension study evaluated the efficacy, safety, and tolerability of continuous oral ADMINISTRATION of FCN-011 in patients with inoperable NTRK fusion and advanced stage III or IV solid tumors, as well as the characteristics of population pharmacokinetics (PopPK). A total of 35-82 patients were enrolled in this study, 15-24 patients were expected to be enrolled in the phase I study, and 20-58 patients were expected to be enrolled in the phase II study.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	FCN-011	FCN-011 will be given orally in ascending doses starting at 50 mg Q12h or 100mg QD until the maximum tolerated dose or recommended dose is reached.

Timeline

• Start date: 2021-04-13
• Primary completion: 2023-10-31
• Completion: 2024-03-31
• First posted: 2020-12-29
• Last updated: 2021-08-18

Locations

1 site across 1 country: China