NCT05051241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

September 2, 2021

Results QC Date

July 6, 2023

Last Update Submit

February 28, 2024

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Incidence of Dose-limiting Toxicity (DLT) Events

    31 days after the first dose

Study Arms (10)

Dose escalation Cohort 1

EXPERIMENTAL

5 mg BID, 14d-on/14d-off

Drug: GFH018

Dose escalation Cohort 2

EXPERIMENTAL

10 mg BID, 14d-on/14d-off

Drug: GFH018

Dose escalation Cohort 3

EXPERIMENTAL

20 mg BID, 14d-on/14d-off

Drug: GFH018

Dose escalation Cohort 4

EXPERIMENTAL

30 mg BID, 14d-on/14d-off

Drug: GFH018

Dose escalation Cohort 5

EXPERIMENTAL

40 mg BID, 14d-on/14d-off

Drug: GFH018

Dose escalation Cohort 6

EXPERIMENTAL

50 mg BID, 14d-on/14d-off

Drug: GFH018

Dose escalation Cohort 7

EXPERIMENTAL

65 mg BID, 14d-on/14d-off

Drug: GFH018

Dose escalation Cohort 8

EXPERIMENTAL

85 mg BID, 14d-on/14d-off

Drug: GFH018

Dose escalation Cohort 9

EXPERIMENTAL

85 mg BID, 7d-on/7d-off

Drug: GFH018

Dose expansion Cohort 10

EXPERIMENTAL

85 mg BID, 14d-on/14d-off

Drug: GFH018

Interventions

GFH018DRUG

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.

Dose escalation Cohort 1Dose escalation Cohort 2Dose escalation Cohort 3Dose escalation Cohort 4Dose escalation Cohort 5Dose escalation Cohort 6Dose escalation Cohort 7Dose escalation Cohort 8Dose escalation Cohort 9Dose expansion Cohort 10

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East hospital

Shanghai, China

Location

Related Publications (1)

  • Guo Y, Wang Z, Zhou H, Pan H, Han W, Deng Y, Li Q, Xue J, Ge X, Wang S, Wang J, Zhang Y, Zhao C, Zhu H, Wang Y, Shen H, Liu D, Li J. First-in-human study of GFH018, a small molecule inhibitor of transforming growth factor-beta receptor I inhibitor, in patients with advanced solid tumors. BMC Cancer. 2024 Apr 10;24(1):444. doi: 10.1186/s12885-024-12216-7.

    PMID: 38600507DERIVED

Results Point of Contact

Title
Yuting Peng
Organization
Zhejiang GenFleet Therapeutics Inc.
ytpeng@genfleet.com
+86 21 6882 1388

Study Officials

  • Jin Li, MD

    Leading site

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 21, 2021

Study Start

August 30, 2019

Primary Completion

August 11, 2022

Study Completion

August 11, 2022

Last Updated

March 1, 2024

Results First Posted

March 1, 2024

Record last verified: 2023-07

Locations

CN(1)