NCT04228406

Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy Evaluation of GST-HG161

Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy Evaluation of the Selective c-MET Inhibitor GST-HG161 in Patients With Advanced or Metastatic Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy evaluation of the selective c-MET inhibitor GST-HG161 in patients with advanced or metastatic solid tumors: An open, single and multiple administration, dose escalation, and expanded phase I trial

Detailed description

This is a phase I trial to evaluate safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy GST-HG161. There are 7 dose cohorts, including60mg, 150mg, 300mg, 450mg, 600mg, 750mg, 900mg QD in the dose escalation stage and GST-HG161 will be administered orally to patients once daily for each dose cohort. Recommended protocal in the dose expansion stage will be determined by the results in the dose escalation stage .

Conditions

• Solid Tumor
• C-Met Mutation-Related Tumors

Interventions

Type	Name	Description
DRUG	GST-HG161	There are 7 dose cohorts, including60mg, 150mg, 300mg, 450mg, 600mg, 750mg, 900mg QD in the dose escalation stage and GST-HG161 will be administered orally to patients once daily for each dose cohort. Recommended dose in the dose expansion stage will be determined by the results in the dose escalation stage .

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-09-30
• Completion: 2020-12-31
• First posted: 2020-01-14
• Last updated: 2020-01-14

Locations

1 site across 1 country: China