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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM97662 | Experimental | Tablet, oral administration, once daily (QD), continuous dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM97662 | Drug | To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of HM97662 in solid tumors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of DLTs | 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 | until Safety Follow-up, 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) | until Cycle 4 Day1 (each cycle is 28 days) | |
| The maximum plasma concentration (Cmax) | until Cycle 4 Day1 (each cycle is 28 days) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiyeon Yoon | Contact | 82-2-410-0368 | mush1223@hanmi.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Research SA | Recruiting | Adelaide | Australia | |||
| Grampians Health |
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| Trough plasma concentration (Ctrough) |
| until Cycle 4 Day1 (each cycle is 28 days) |
| Time to reach Cmax (Tmax) | until Cycle 4 Day1 (each cycle is 28 days) |
| Terminal Half-life (T1/2) | until Cycle 4 Day1 (each cycle is 28 days) |
| Apparent clearance (CL/F) | until Cycle 4 Day1 (each cycle is 28 days) |
| Apparent volume of distribution (Vd/F) | until Cycle 4 Day1 (each cycle is 28 days) |
| Objective response | 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) |
| Recruiting |
| Ballarat |
| Australia |
| Monash Medical Centre | Recruiting | Clayton | Australia |
| Peninsula and Southeast Oncology | Recruiting | Frankston | Australia |
| National Cancer Center | Not yet recruiting | Goyang-si | Gyeonggi-do | South Korea |
| Asan Medical Center | Recruiting | Seoul | South Korea |
| Samsung Medical Center | Not yet recruiting | Seoul | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Seoul | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Recruiting | Seoul | South Korea |