Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
HM97662: To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of HM97662 in solid tumors
Study summary
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.
Eligibility
Primary outcome measure(s)
- 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
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| 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 |
More Hanmi Pharmaceutical Company Limited trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05598151 on ClinicalTrials.gov ↗ ← All trials in South Korea