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NCT Number: NCT05051241

A Study of GFH018 in 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.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai East hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible subjects must meet all the inclusion criteria listed below:
  • Voluntarily participate in this clinical trial and are willing to sign informed consent forms.
  • Male or female aged from 18-75 years old (inclusive).
  • Diagnosed with histologically or cytologically confirmed advanced solid tumors.
  • Evaluable lesions defined by RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • 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:
  • With clinically significant cardiac diseases.
  • With clinically significant digestive disorders.
  • Other severe disease.
  • Pregnant or lactating women.
  • Other unfavorable situations for subjects to participate in the study judged by Investigators.

Treatment and study plan

GFH018

Drug

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.

Primary outcomes

  1. Incidence of Dose-limiting Toxicity (DLT) Events

    Time frame: 31 days after the first dose

Sponsors and collaborators

Lead sponsor

Zhejiang Genfleet Therapeutics Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2021
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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