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An oral drug targets a specific gene flaw in Hard-to-Treat tumors

NCT ID NCT06796699

Disease control Sponsor: Suzhou Genhouse Bio Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 02, 2026 · Last updated Oct 02, 2026

Summary

Researchers are testing an experimental oral drug called GH56 in people with advanced solid tumors that have lost the MTAP gene. The trial enrolls adults and adolescents whose cancer has progressed after standard treatment or who have no standard options left. The study first finds a safe dose, then expands to more participants to look for early signs that the drug shrinks tumors.

What this could mean

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

Active substance
GH56 capsule, an experimental oral cancer drug
What this could lead to
If GH56 works, it could offer an oral treatment option for advanced solid tumors with an MTAP deletion, a group that often has few targeted choices.
What could go wrong
This is an early-phase trial, so researchers mainly check safety and dosing rather than whether the drug extends life. Many experimental cancer drugs fail at this stage, and GH56 may cause side effects or show too little benefit.

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 200 people

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

Started

Mar 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

12 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: 1. Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures. 2. Male and female patients who are ≥12 years of age at consent . 3. Histologically or cytologically confirmed advanced and/or metastatic malignancies with progression on / intolerance to standard treatment or lack of effective standard treatment. 4. Evidence of MTAP loss or homozygous MTAP/CDKN2A deletion in tumor tissue. 5. At least one measurable lesion as per RECIST v1.1 criteria. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. 7. Survival expectations ≥ 12 weeks. 8. Adequate organ function 9. Has a negative serum pregnancy test result at screening and is able to comply with contraceptive-barrier requirements. Exclusion Criteria: 1. Subject has not recovered from a prior surgical procedure or has undergone any major surgery within 4 weeks prior to the first dose. 2. Has received any anti-tumor agents within 28 days without delayed toxicity for the treatment of advanced tumors prior to the first administration of GH56 Capsule 3. Has symptomatic or active progressive central nervous system (CNS) metastases such as molluscum contagiosum metastases. 4. Subjects who have difficulty in swallowing and have a history of gastrointestinal surgery or other relevant medical disorders that may interfere with the absorption of GH56. 5. Subjects had a malignant tumor other than the current tumor within 5 years prior to the first administration of GH56 Capsule, except for localized cancers that have been apparently cured or without disease progression or recurrence for at least 5 consecutive years. 6. Uncontrolled or significant cardiovascular disease 7. Subjects with documented positive virology status of hepatitis, as confirmed by Screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests, Human Immunodeficiency Virus (HIV). 8. Conditions that the investigator considers inappropriate for participation in this clinical trial.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumors with MTAP deletion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tiantan Hospital,Capital Medical University

    ACTIVE_NOT_RECRUITING

    Beijing, Beijing Municipality, 100070, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • China-Japan Union Hospital of Jilin University

    ACTIVE_NOT_RECRUITING

    Changchun, Jilin, 130033, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Gansu Provincial Hospital

    RECRUITING

    Lanzhou, Gansu, 730000, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi, 530200, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Nanfang Hospital

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Shandong Medical and Pharmaceutical University Hospital

    RECRUITING

    Binzhou, Shandong, 256603, China

  • Shanghai GoBroad Caner Hospital China Pharmaceutical University

    RECRUITING

    Shanghai, Shanghai Municipality, 201200, China

  • Shanghai Sixth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200233, China

  • Shanxi Provincial Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, 30009, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Taizhou, Zhejiang, 317000, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The First Teaching Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, Uygur Autonomous Region, 830054, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • The Second People's Hospital of Guiyang

    RECRUITING

    Guiyang, Guizhou, 550081, China

  • The Second People's Hospital of Yibin

    RECRUITING

    Yibin, Sichuan, 644000, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410008, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

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