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A Study of GFH018 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05051241
Recruitment Status : Not yet recruiting
First Posted : September 21, 2021
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Genfleet Therapeutics (Shanghai) Inc. ( Zhejiang Genfleet Therapeutics Co., Ltd. )

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: GFH018 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : November 2022

Arm Intervention/treatment
Experimental: GFH018

The duration of the first cycle is 31 days and the subsequent periods are 28 days.

Subjects will receive treatment with GFH018 until disease progression (clinically- or radiologically-confirmed), occurrence of intolerable toxicity, or subjects discontinue from the study treatment for other reasons.

Drug: GFH018
Subjects will receive GFH018 orally at different dose levels following twice daily, 14-day on/14-day off regimen.




Primary Outcome Measures :
  1. Phase I:Incidence of dose-limiting toxicity (DLT) events [ Time Frame: 31 days after the first dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05051241


Contacts
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Contact: Jenny Liu +86 21 6882 1388 wliu@genfleet.com

Locations
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China
Shanghai East hospital
Shanghai, China
Contact: Jin Li, MD         
Sponsors and Collaborators
Zhejiang Genfleet Therapeutics Co., Ltd.
Investigators
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Principal Investigator: Jin Li, MD Leading site
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Responsible Party: Zhejiang Genfleet Therapeutics Co., Ltd.
ClinicalTrials.gov Identifier: NCT05051241    
Other Study ID Numbers: GFH018X1101
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms