A Study of GFH018 in Patients With Advanced Solid Tumors
JL
Overseen byJin Li, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Zhejiang Genfleet Therapeutics Co., Ltd.
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Research Team
JL
Jin Li, MD
Principal Investigator
Leading site
Eligibility Criteria
Inclusion Criteria
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.
See 3 more
Treatment Details
Interventions
- GFH018 (Monoclonal Antibodies)
Participant Groups
10Treatment groups
Experimental Treatment
Group I: Dose expansion Cohort 10Experimental Treatment1 Intervention
85 mg BID, 14d-on/14d-off
Group II: Dose escalation Cohort 9Experimental Treatment1 Intervention
85 mg BID, 7d-on/7d-off
Group III: Dose escalation Cohort 8Experimental Treatment1 Intervention
85 mg BID, 14d-on/14d-off
Group IV: Dose escalation Cohort 7Experimental Treatment1 Intervention
65 mg BID, 14d-on/14d-off
Group V: Dose escalation Cohort 6Experimental Treatment1 Intervention
50 mg BID, 14d-on/14d-off
Group VI: Dose escalation Cohort 5Experimental Treatment1 Intervention
40 mg BID, 14d-on/14d-off
Group VII: Dose escalation Cohort 4Experimental Treatment1 Intervention
30 mg BID, 14d-on/14d-off
Group VIII: Dose escalation Cohort 3Experimental Treatment1 Intervention
20 mg BID, 14d-on/14d-off
Group IX: Dose escalation Cohort 2Experimental Treatment1 Intervention
10 mg BID, 14d-on/14d-off
Group X: Dose escalation Cohort 1Experimental Treatment1 Intervention
5 mg BID, 14d-on/14d-off
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zhejiang Genfleet Therapeutics Co., Ltd.
Lead Sponsor
Trials
11
Recruited
900+