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A Study of GFH018 in Patients With Advanced Solid Tumors

NCT05051241 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-01

Study results available
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Summary

This is the first- in human study of GFH018 comprised of a dose escalation part and a dose expansion part in subjects with advanced solid tumors after single/multiple administration. The study is designed to explore the safety/tolerability, pharmacokinetics, and MTD of GFH018 and to define a RP2D of GFH018.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

GFH018

Subjects will receive GFH018 orally at different dose levels following twice daily, 14-day on/14-day off regimen. Other dose regimens, eg 7d-on/7d-off will also be considered to be explored when the safety/tolerability is confirmed.

Sponsors & Collaborators

  • Zhejiang Genfleet Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jin Li, MD · Leading site

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-30
Primary Completion
2022-08-11
Completion
2022-08-11

Countries

  • China

Study Locations

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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 NCT05051241 on ClinicalTrials.gov