Advanced or Metastatic Solid TumorsPhase 1NCT05598151
Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors
A Phase 1 study testing HM97662 in people with Advanced or Metastatic Solid Tumors, run by Hanmi Pharmaceutical Company Limited at 10 sites in 2 countries.
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 is comprised of Dose-Escalation Part followed by randomized Dose-Ranging Part and Dose-Expansion Part. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- HM97662
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 11 Jan 2023to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 randomized dose-ranging and 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.
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- 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.
- For Dose-Ranging Part, documentation of an alteration in at least one of the genes of the SWI/SNF complex in tumor tissue (archival or newly obtained).
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
South Korea6 sites
National Cancer Center
Goyang-si, Gyeonggi-do
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Bundang Hospital
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
Australia4 sites
Cancer Research SA
Adelaide
Grampians Health
Ballarat
Monash Medical Centre
Clayton
Peninsula and Southeast Oncology
Frankston
About this study
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
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
- Advanced or Metastatic Solid Tumors
- Being tested
- HM97662
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM97662Drug
To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of HM97662 in solid tumors
| Study group | Role | What they receive |
|---|---|---|
| HM97662 | Experimental | Tablet, oral administration, once daily (QD), continuous dosing Receives: Drug: HM97662 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of DLTs
Measured: Days 1-28 of Cycle 1 (DLT assessment period) in Dose-Escalation Part
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI CTCAE v5.0
Measured: 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 outcomes (8)
Area under the concentration-time curve (AUC)
Measured: until Cycle 4 Day1 (each cycle is 28 days)
The maximum plasma concentration (Cmax)
Measured: until Cycle 4 Day1 (each cycle is 28 days)
Trough plasma concentration (Ctrough)
Measured: until Cycle 4 Day1 (each cycle is 28 days)
Time to reach Cmax (Tmax)
Measured: until Cycle 4 Day1 (each cycle is 28 days)
Terminal Half-life (T1/2)
Measured: until Cycle 4 Day1 (each cycle is 28 days)
Apparent clearance (CL/F)
Measured: until Cycle 4 Day1 (each cycle is 28 days)
Apparent volume of distribution (Vd/F)
Measured: until Cycle 4 Day1 (each cycle is 28 days)
Objective response
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start11 Jan 2023
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598151
- Sponsor's protocol ID
- HM-EZHI-101
- Status last verified
- Aug 2026
- First submitted
- 5 Sep 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05598151
- Acronym / sponsor ID
- HM-EZHI-101
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HM97662 | Experimental | Drug: HM97662Tablet, oral administration, once daily (QD), continuous dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 randomized dose-ranging and 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM97662To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of HM97662 in solid tumors | Drug | HM97662 |
Primary outcome
Incidence and nature of DLTs
Time frame: Days 1-28 of Cycle 1 (DLT assessment period) in Dose-Escalation Part
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI CTCAE v5.0
Time frame: until Safety Follow-up, 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first
8 secondary outcomes
Area under the concentration-time curve (AUC)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
The maximum plasma concentration (Cmax)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Trough plasma concentration (Ctrough)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Time to reach Cmax (Tmax)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Terminal Half-life (T1/2)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Apparent clearance (CL/F)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Apparent volume of distribution (Vd/F)
Time frame: until Cycle 4 Day1 (each cycle is 28 days)
Objective response
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HM97662 in people with Advanced or Metastatic Solid Tumors, run by Hanmi Pharmaceutical Company Limited at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and nature of DLTs (time frame: Days 1-28 of Cycle 1 (DLT assessment period) in Dose-Escalation Part). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.