A Study of GFH018 in Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: GFH018

• Registration Number: NCT05051241
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-30
• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-21
• Primary Completion: 2022-08-11
• Study Completion: 2022-08-11
• Status Verified: 2023-07
• Results First Submitted: 2023-07-06
• Results First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Results First Posted: 2024-03-01
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation Cohort 2	GFH018	10 mg BID, 14d-on/14d-off
Dose escalation Cohort 3	GFH018	20 mg BID, 14d-on/14d-off
Dose escalation Cohort 4	GFH018	30 mg BID, 14d-on/14d-off
Dose escalation Cohort 5	GFH018	40 mg BID, 14d-on/14d-off
Dose escalation Cohort 6	GFH018	50 mg BID, 14d-on/14d-off
Dose escalation Cohort 1	GFH018	5 mg BID, 14d-on/14d-off
Dose escalation Cohort 7	GFH018	65 mg BID, 14d-on/14d-off
Dose escalation Cohort 8	GFH018	85 mg BID, 14d-on/14d-off
Dose escalation Cohort 9	GFH018	85 mg BID, 7d-on/7d-off
Dose expansion Cohort 10	GFH018	85 mg BID, 14d-on/14d-off

Primary Outcome Measures

Name	Time	Method
Incidence of Dose-limiting Toxicity (DLT) Events	31 days after the first dose

Trial Locations

Locations (1)

Shanghai East hospital; 🇨🇳 Shanghai, China