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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05598151




Registration number
NCT05598151
Ethics application status
Date submitted
5/09/2022
Date registered
28/10/2022
Date last updated
15/06/2023

Titles & IDs
Public title
Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors
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
Secondary ID [1] 0 0
HM-EZHI-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HM97662

Experimental: HM97662 - Tablet, oral administration, once daily (QD), continuous dosing


Treatment: Drugs: HM97662
To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of HM97662 in solid tumors
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and nature of DLTs
Timepoint [1] 0 0
Days 1-28 of Cycle 1 (DLT assessment period) in Dose-Escalation Part
Primary outcome [2] 0 0
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI CTCAE v5.0
Timepoint [2] 0 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 outcome [1] 0 0
Area under the concentration-time curve (AUC)
Timepoint [1] 0 0
until Cycle 4 Day1 (each cycle is 28 days)
Secondary outcome [2] 0 0
The maximum plasma concentration (Cmax)
Timepoint [2] 0 0
until Cycle 4 Day1 (each cycle is 28 days)
Secondary outcome [3] 0 0
Trough plasma concentration (Ctrough)
Timepoint [3] 0 0
until Cycle 4 Day1 (each cycle is 28 days)
Secondary outcome [4] 0 0
Time to reach Cmax (Tmax)
Timepoint [4] 0 0
until Cycle 4 Day1 (each cycle is 28 days)
Secondary outcome [5] 0 0
Terminal Half-life (T1/2)
Timepoint [5] 0 0
until Cycle 4 Day1 (each cycle is 28 days)
Secondary outcome [6] 0 0
Apparent clearance (CL/F)
Timepoint [6] 0 0
until Cycle 4 Day1 (each cycle is 28 days)
Secondary outcome [7] 0 0
Apparent volume of distribution (Vd/F)
Timepoint [7] 0 0
until Cycle 4 Day1 (each cycle is 28 days)
Secondary outcome [8] 0 0
Objective response
Timepoint [8] 0 0
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)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [2] 0 0
Grampians Health - Ballarat
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Peninsula and Southeast Oncology - Frankston
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Ballarat
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Frankston
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hanmi Pharmaceutical Company Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05598151
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jiyeon Yoon
Address 0 0
Country 0 0
Phone 0 0
82-2-410-0368
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05598151