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

Advanced or Metastatic Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598151
• Other study ID #: HM-EZHI-101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 11, 2023
• Est. completion date: June 2028

Study information

• Verified date: June 2023
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Jiyeon Yoon
• Phone: 82-2-410-0368
• Email: mush1223[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2028
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• HM97662
To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of HM97662 in solid tumors

Locations

Country	Name	City	State
Australia	Cancer Research SA	Adelaide
Australia	Grampians Health	Ballarat
Australia	Monash Medical Centre	Clayton
Australia	Peninsula and Southeast Oncology	Frankston
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Countries where clinical trial is conducted

Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of DLTs		Days 1-28 of Cycle 1 (DLT assessment period) in Dose-Escalation Part
Primary	Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI CTCAE v5.0		until Safety Follow-up, 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first
Secondary	Area under the concentration-time curve (AUC)		until Cycle 4 Day1 (each cycle is 28 days)
Secondary	The maximum plasma concentration (Cmax)		until Cycle 4 Day1 (each cycle is 28 days)
Secondary	Trough plasma concentration (Ctrough)		until Cycle 4 Day1 (each cycle is 28 days)
Secondary	Time to reach Cmax (Tmax)		until Cycle 4 Day1 (each cycle is 28 days)
Secondary	Terminal Half-life (T1/2)		until Cycle 4 Day1 (each cycle is 28 days)
Secondary	Apparent clearance (CL/F)		until Cycle 4 Day1 (each cycle is 28 days)
Secondary	Apparent volume of distribution (Vd/F)		until Cycle 4 Day1 (each cycle is 28 days)
Secondary	Objective response		Day 1 of Cycles 3, 5, 7 (each cycle is 28 days) and further (every 8 weeks) until disease progression (assessed up to 5 years)