NCT04914286

A Study of GFH018 in Combination With Toripalimab in Patients With Advanced Solid Tumors

A Multi-center, Single-arm, and Open-label Phase Ib/II Study Exploring the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH018 in Combination With Toripalimab in the Treatment of Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Genfleet Therapeutics (Shanghai) Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety/tolerability, pharmacokinetics, and preliminary efficacy of GFH018 in combination with Toripalimab in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	GFH018	Subjects are planned to be dosed in oral GFH018 tablets twice daily for a continuous 14 days in a 28 days cycle (7days on 7days off may be tested based on available data from phase I dose escalation study of single agent). the starting dose of GFH018 will be derived from the maximum safe dose explored in rom phase I dose escalation study of single agent.
DRUG	Toripalimab	Subjects are planned to be dosed at 3 mg/kg Toripalimab as an intravenous infusion once every 2 weeks.

Timeline

• Start date: 2021-10-20
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-06-04
• Last updated: 2025-05-14

Locations

3 sites across 2 countries: Australia, China