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Trial 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.

Acronym:

EZHI

ACTRN/NCT /ethics:

NCT05598151

Scientific title:

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

Sponsor / Cooperative group:

Hanmi Pharmaceutical Company Limited

Trial & Patient Characteristics

Cancer TypeAll cancers
Trial TypeTreatment
PhasePhase I
Age Range18 years and older
SexAll
Tumour Stream -
Cancer Stage-
Anticipated Start Date2023-01-11
Anticipated End Date2028-06-01

Participating Hospitals

HospitalCancer Research SA
Clinical Trial CoordinatorKelly Mead/Kate Penta
Emailadmin@cancerresearchsa.com.au
Phone08 8359 2565
Principal InvestigatorSarwan Bishnoi
Recruitment StatusRecruiting