NCT03457532

A Phase I Study of SCC244 in Patients with Advanced MET Alterations Solid Tumors

An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characters, and Preliminary Efficacy of SCC244 in Patients with Advanced MET Alterations Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Haihe Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1a/1b multi-center and open label study to evaluate the safety, tolorability, pharmacokinetics and priliminary efficacy of SCC244 in advanced solid tumors patients with c-MET alteration

Detailed description

This is a phase I study, its purpose to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD)/ biologically effective dose (BED) and the recommended phase II dose (RP2D) of SCC244 monotherapy in patients with advanced MET alterations solid tumors;

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Gumarontinib Tablets	25mg; 50mg; 100mg; 200mg; 400mg; 600mg BID or QD(Decided by SMC accroding to the safty and PK data)

Timeline

• Start date: 2017-12-16
• Primary completion: 2023-09-22
• Completion: 2023-09-22
• First posted: 2018-03-07
• Last updated: 2024-11-01

Locations

1 site across 1 country: China