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RecruitingLast updated: 24 October 2024

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

Clinical summary

Summary

This study will be conducted in two parts: Dose Escalation and Dose Expansion.

The Dose Escalation part is planned with a 3+3 Dose Escalation design, and will seek to establish the maximum tolerated dose (MTD) or recommended dose (RD) of HM97662 for the Dose Expansion Part. The Dose Escalation Part will recruit people from multiple cancer types.

The Dose Expansion Part is designed to assess the effectiveness of HM97662 when administered at the Recommended Dose to people with specific cancer types. HM97662 will be administered as an oral tablet once daily.

Conditions

This trial is treating patients with advanced or metastatic solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

HM-EZH-101

More information

Trial Identifiers

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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

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 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.

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.
  • Your cancer has not spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

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.

Ask your doctor if this trial could be right for you.

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