A Study of GFH018 in Patients With Advanced Solid Tumors

GenFleet Therapeutics

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: GFH018

Study type: Interventional

Funder types: Industry

Identifiers

NCT05051241

GFH018X1101

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 10 patient groups

Dose escalation Cohort 1

Experimental group

Description:

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

Treatment:

Drug: GFH018

Dose escalation Cohort 2

Experimental group

Description:

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

Treatment:

Drug: GFH018

Dose escalation Cohort 3

Experimental group

Description:

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

Treatment:

Drug: GFH018

Dose escalation Cohort 4

Experimental group

Description:

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

Treatment:

Drug: GFH018

Dose escalation Cohort 5

Experimental group

Description:

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

Treatment:

Drug: GFH018

Dose escalation Cohort 6

Experimental group

Description:

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

Treatment:

Drug: GFH018

Dose escalation Cohort 7

Experimental group

Description:

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

Treatment:

Drug: GFH018

Dose escalation Cohort 8

Experimental group

Description:

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

Treatment:

Drug: GFH018

Dose escalation Cohort 9

Experimental group

Description:

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

Treatment:

Drug: GFH018

Dose expansion Cohort 10

Experimental group

Description:

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

Treatment:

Drug: GFH018