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

NCT04228406 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-01-14

No results posted yet for this study

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

Conditions

Interventions

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 .

Sponsors & Collaborators

  • Fujian Cosunter Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • JI LI, PHD · Shanghai Oriental Hospital ,China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-09-30
Completion
2020-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04228406 on ClinicalTrials.gov