A Study of GFH018 in Patients With Advanced Solid Tumors

February 28, 2024 updated by: Zhejiang Genfleet Therapeutics Co., Ltd.

A Phase I Study With Single/Multiple Dose Administered to Explore the Safety/Tolerability and Pharmacokinetics of GFH018 in the Treatment of Patients With Advanced Solid Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai East Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eligible subjects must meet all the inclusion criteria listed below:

    1. Voluntarily participate in this clinical trial and are willing to sign informed consent forms.
    2. Male or female aged from 18-75 years old (inclusive).
    3. Diagnosed with histologically or cytologically confirmed advanced solid tumors.
    4. Evaluable lesions defined by RECIST v1.1.
    5. Eastern Cooperative Oncology Group performance status of 0 to 1.
    6. Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.

Exclusion Criteria:

  • Eligible subjects should not meet any of the exclusion criteria listed below:

    1. With clinically significant cardiac diseases.
    2. With clinically significant digestive disorders.
    3. Other severe disease.
    4. Pregnant or lactating women.
    5. Other unfavorable situations for subjects to participate in the study judged by Investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose escalation Cohort 1
5 mg BID, 14d-on/14d-off
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.
Experimental: Dose escalation Cohort 2
10 mg BID, 14d-on/14d-off
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.
Experimental: Dose escalation Cohort 3
20 mg BID, 14d-on/14d-off
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.
Experimental: Dose escalation Cohort 4
30 mg BID, 14d-on/14d-off
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.
Experimental: Dose escalation Cohort 5
40 mg BID, 14d-on/14d-off
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.
Experimental: Dose escalation Cohort 6
50 mg BID, 14d-on/14d-off
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.
Experimental: Dose escalation Cohort 7
65 mg BID, 14d-on/14d-off
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.
Experimental: Dose escalation Cohort 8
85 mg BID, 14d-on/14d-off
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.
Experimental: Dose escalation Cohort 9
85 mg BID, 7d-on/7d-off
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.
Experimental: Dose expansion Cohort 10
85 mg BID, 14d-on/14d-off
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Dose-limiting Toxicity (DLT) Events
Time Frame: 31 days after the first dose
31 days after the first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Genfleet Therapeutics Co., Ltd.

Investigators

  • Principal Investigator: Jin Li, MD, Leading site

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2019

Primary Completion (Actual)

August 11, 2022

Study Completion (Actual)

August 11, 2022

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFH018X1101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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