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RecruitingLast updated: 30 June 2026

HM-EZH-101: This study is assessing how safe and effective a new targeted therapy (called HM97662) is in people with advanced or metastatic solid cancersA Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM97662 as a Single Agent in Patients With Advanced or Metastatic Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

HM-EZH-101

Clinical summary

Summary

This is a study to see how safe and effective a targeted drug called HM97662 is, as well as how it interacts with the body and what the recommended dose is. HM97662 is an EZH1/2 dual inhibitor.

The study is comprised of a Dose Escalation Part, followed by a randomised Dose Ranging Part and a Dose Expansion Part.

The Dose Escalation Part will seek to establish the maximum tolerated dose (MTD) or recommended dose (RD) of HM97662 when given by itself (monotherapy).

The Dose Ranging Part is designed mainly to further evaluate how safe and effective HM97662 is as monotherapy in people with specific genomic alterations, to more precisely determine the potential recommended phase 2 dose (RP2D) to be tested in the Dose Expansion Part. To be enrolled in this part, participants must have an alteration in at least one of the genes of SWI/SNF complex (EZH2, ARID1A, SMARCB1, SMARCA4, KDM6A).

The Dose Expansion Part is designed to assess the potential efficacy of HM97662 monotherapy when given at the RP2D identified in the previous part, in people with specific cancer types. 

Conditions

This trial is treating people with advanced or metastatic solid cancers

Eligibility

Inclusion

  • Histologically and/or cytologically confirmed advanced or metastatic solid tumor who have failed/are intolerant to standard therapy.
  • Patients for dose-escalation part must have evaluable or measurable disease at baseline and the patients for randomized dose-ranging and dose-expansion part must have at least one measurable lesion at baseline by CT or MRI per Response Evaluation Criteria in Solid Tumor (RECIST v1.1).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 3 months before starting HM97662.
  • Adequate renal function.
  • Adequate hematologic function.
  • Adequate liver function.
  • Males or females aged ≥ 18 years (or country's legal age of majority if the legal age was > 18 years) at the time of informed consent.
  • For Dose-Ranging Part, documentation of an alteration in at least one of the genes of the SWI/SNF complex in tumor tissue (archival or newly obtained).

Exclusion

  • Prior exposure to valemetostat or other EZH1/2 dual inhibitor.
  • Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
  • Patients currently taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers.
  • Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
  • Major surgery within 4 weeks before the first dose of study drug treatment in Cycle 1.
  • Females who are pregnant or breastfeeding.
  • Patients who have undergone an organ transplant.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Hanmi Pharmaceutical Company Limited

Scientific 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

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