A Study of GFH018 in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05051241
• Other study ID #: GFH018X1101
• Status: Completed
• Phase: Phase 1
• Start date: August 30, 2019
• Est. completion date: August 11, 2022

Study information

• Verified date: July 2023
• Source: Genfleet Therapeutics (Shanghai) Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 11, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai East hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Genfleet Therapeutics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dose-limiting Toxicity (DLT) Events		31 days after the first dose