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.

GFH018

Jin Li, MD

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.

A Study of GFH018 in Patients With Advanced Solid Tumors

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

Zhejiang Genfleet Therapeutics Co., Ltd.

TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. Serious adverse events with an onset or worsening ≥30 days after the last dose, if related to the study treatment, are also TEAEs.

Participants in Cohort 1 received GFH018 5 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 1 5 mg BID, 14d-on/14d-off

Participants in Cohort 2 received GFH018 10 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 2 10 mg BID, 14d-on/14d-off

Participants in Cohort 3 received GFH018 10 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 3 20 mg BID, 14d-on/14d-off

Participants in Cohort 4 received GFH018 30 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 4 30 mg BID, 14d-on/14d-off

Participants in Cohort 5 received GFH018 40 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 5 40 mg BID, 14d-on/14d-off

Participants in Cohort 6 received GFH018 50 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 6 50 mg BID, 14d-on/14d-off

Participants in Cohort 7 received GFH01865 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 7 65 mg BID, 14d-on/14d-off

Participants in Cohort 8 received GFH018 85 mg BID, 14d-on/14d-off orally

Dose Escalation: Cohort 8 85 mg BID, 14d-on/14d-off

Participants in Cohort 9 received GFH018 85 mg BID, 7d-on/17d-off orally

Dose Escalation: Cohort 9 85 mg BID, 7d-on/7d-off

Participants in Cohort 10 received GFH018 85 mg BID, 14d-on/14d-off orally

Dose Expansion: Cohort 10 85 mg BID, 14d-on/14d-off

Dose Escalation Cohort 1 5 mg BID, 14d-on/14d-off

Participants in Cohort 2 received GFH018 10 mg BID, 14d-on/14d-off

Participants in Cohort 3 received GFH018 20 mg BID, 14d-on/14d-off

Participants in Cohort 4 received GFH018 30 mg BID, 14d-on/14d-off

Participants in Cohort 5 received GFH018 40 mg BID, 14d-on/14d-off

Participants in Cohort 6 received GFH018 50 mg BID, 14d-on/14d-off

Participants in Cohort 7 received GFH018 65 mg BID, 14d-on/14d-off

Participants in Cohort 8 received GFH018 85 mg BID, 14d-on/14d-off

Participants in Cohort 9 received GFH018 85 mg BID, 7d-on/7d-off

Participants in Cohort 10 received GFH018 85 mg BID, 14d-on/14d-off

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

China

Region of Enrollment

Yuting Peng

Participants in Cohort 3 received GFH018 20 mg BID, 14d-on/14d-off orally

Participants in Cohort 7 received GFH018 65 mg BID, 14d-on/14d-off orally

Participants in Cohort 9 received GFH018 85 mg BID, 7d-on/7d-off orally

Participants enrolled in the expansion part were NOT included in analyzing the incidence of DLT. So the analyzed number of cohort 10 was 0.

Spots Global Cancer Trial Database for A Study of GFH018 in Patients With Advanced Solid Tumors

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