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Brief Title: Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors
Official Title: A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM97662 as a Single Agent in Patients With Advanced or Metastatic Solid Tumors
Study ID: NCT05598151
Brief 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 will be conducted in Dose-Escalation and Dose-Expansion parts. Dose-Escalation Part is planned with a 3+3 Dose-Escalation design and is to establish the MTD or RD for Dose-Expansion part of HM97662 as a single agent in subjects with advanced or metastatic solid tumors. Dose-Expansion Part is designed to assess the potential efficacy of HM97662 monotherapy when administered at the RD to subjects in indication-specific expansion cohorts.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer Research SA, Adelaide, , Australia
Grampians Health, Ballarat, , Australia
Monash Medical Centre, Clayton, , Australia
Peninsula and Southeast Oncology, Frankston, , Australia
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University Bundang Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital., Seoul, , Korea, Republic of