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Can a dual protein blocker shrink Hard-to-Treat tumors?

NCT ID NCT05598151

Disease control Sponsor: Hanmi Pharmaceutical Company Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called HM97662 in people with advanced or metastatic solid tumors that have not responded to standard treatments. The drug works by blocking two proteins, EZH1 and EZH2, which are thought to help tumors grow. The study aims to find the safest dose, understand how the drug behaves in the body, and see if it can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HM97662, an experimental drug that blocks two proteins (EZH1 and EZH2) involved in tumor growth
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is an early-phase trial, so the drug may not work as hoped or may cause unexpected side effects. Results are preliminary and need confirmation in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. * 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). 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.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic solid tumors

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, South Korea

  • Cancer Research SA

    Adelaide, Australia

  • Grampians Health

    Ballarat, Australia

  • Monash Medical Centre

    Clayton, Australia

  • National Cancer Center

    Goyang-si, Gyeonggi-do, South Korea

  • Peninsula and Southeast Oncology

    Frankston, Australia

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul, South Korea

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