Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors

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.

NCT Number	NCT05598151
Lead Sponsor	Hanmi Pharmaceutical Company Limited
Conditions	Advanced or Metastatic Solid Tumors
Enrollment	170 participants
Start Date	2023-01-11
Primary Completion	2028-01 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2026-08-12