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

• Status: Not yet recruiting
• Trial end date: 2028-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.