Actively Recruiting
Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors
Led by Hanmi Pharmaceutical Company Limited · Updated on 2025-04-30
170
Participants Needed
10
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase1 study to assess the safety, PK, PD and efficacy of HM97662, EZH1/2 dual inhibitor, in solid tumors. The study is comprised of Dose-Escalation Part followed by randomized Dose-Ranging Part and Dose-Expansion Part. Dose-Escalation Part is planned with a 3+3 Dose-Escalation design and is to establish the MTD or RD for randomized Dose-Ranging Part. Dose-Ranging Part is designed mainly to further evaluate safety and preliminary efficacy of HM97662 monotherapy in subjects with specific genomic alterations to more precisely determine the potential RP2D that are to be tested in a Dose-Expansion Part. Dose-Expansion Part is designed to assess the potential efficacy of HM97662 monotherapy when administered at the RP2D to subjects in indication-specific expansion cohorts.
CONDITIONS
Official Title
Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and/or cytologically confirmed advanced or metastatic solid tumor who have failed or are intolerant to standard therapy.
- Patients in the dose-escalation part must have evaluable or measurable disease at baseline.
- Patients in the randomized dose-ranging and dose-expansion parts must have at least one measurable lesion at baseline by CT or MRI per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months before starting HM97662.
- Adequate kidney function.
- Adequate blood cell counts.
- Adequate liver function.
- Males or females aged 18 years or older (or country's legal age of majority if higher) at informed consent.
- For dose-ranging part, documented alteration in at least one gene of the SWI/SNF complex in tumor tissue (archival or newly obtained).
You will not qualify if you...
- Prior exposure to valemetostat or other EZH1/2 dual inhibitors.
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
- Currently taking medications that are strong CYP3A inhibitors or strong/moderate CYP3A inducers.
- Clinically significant toxicities from prior treatments that have not resolved to Grade 1 or lower per CTCAE v5.0 or are clinically unstable.
- Major surgery within 4 weeks before first dose of study drug.
- Females who are pregnant or breastfeeding.
- Patients who have had an organ transplant.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Cancer Research SA
Adelaide, Australia
Actively Recruiting
2
Grampians Health
Ballarat, Australia
Actively Recruiting
3
Monash Medical Centre
Clayton, Australia
Actively Recruiting
4
Peninsula and Southeast Oncology
Frankston, Australia
Actively Recruiting
5
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Not Yet Recruiting
6
Asan Medical Center
Seoul, South Korea
Actively Recruiting
7
Samsung Medical Center
Seoul, South Korea
Not Yet Recruiting
8
Seoul National University Bundang Hospital
Seoul, South Korea
Actively Recruiting
9
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
10
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
Jiyeon Yoon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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