This is a Phase1 study to assess the safety, PK, PD and efficacy of HM97662, EZH1/2 dual inhibitor, in solid tumors. The study is comprised of Dose-Escalation Part followed by randomized Dose-Ranging Part and Dose-Expansion Part. Dose-Escalation Part is planned with a 3+3 Dose-Escalation design and is to establish the MTD or RD for randomized Dose-Ranging Part. Dose-Ranging Part is designed mainly to further evaluate safety and preliminary efficacy of HM97662 monotherapy in subjects with specific genomic alterations to more precisely determine the potential RP2D that are to be tested in a Dose-Expansion Part. Dose-Expansion Part is designed to assess the potential efficacy of HM97662 monotherapy when administered at the RP2D to subjects in indication-specific expansion cohorts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
170
To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of HM97662 in solid tumors
Cancer Research SA
Adelaide, Australia
Grampians Health
Ballarat, Australia
Monash Medical Centre
Clayton, Australia
Peninsula and Southeast Oncology
Frankston, Australia
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
Incidence and nature of DLTs
Time frame: Days 1-28 of Cycle 1 (DLT assessment period) in Dose-Escalation Part
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI CTCAE v5.0
Time frame: until Safety Follow-up, 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first
Area under the concentration-time curve (AUC)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
The maximum plasma concentration (Cmax)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Trough plasma concentration (Ctrough)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Time to reach Cmax (Tmax)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Terminal Half-life (T1/2)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Apparent clearance (CL/F)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Apparent volume of distribution (Vd/F)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Objective response
Time frame: Day 1 of Cycles 3, 5, 7 (each cycle is 28 days) and further (every 8 weeks) until disease progression (assessed up to 5 years)
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