Experimental pill HG146 put to the test against rare head and neck cancer

NCT ID NCT06781567

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing an experimental drug called HG146 in people with adenoid cystic carcinoma that has come back or spread. The trial enrolls about 140 adults and gives them HG146 capsules to see if the drug can shrink tumors or slow cancer growth. Doctors track tumor response and how long participants live without their cancer getting worse.

What this could mean

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

Active substance
HG146, an experimental capsule drug
What this could lead to
If HG146 works, it could offer a new treatment option for people with recurrent or metastatic adenoid cystic carcinoma, a cancer with few effective therapies.
What could go wrong
This is a phase 2 trial, so the drug's effectiveness and safety are still unproven. It may not shrink tumors or slow progression, and it could cause side effects that outweigh any 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 140 people

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

Started

Dec 2024

Expected to finish

Jun 2029

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: * Signed informed consent form (ICF) and able to comply with study. * Age ≥18 years, gender unlimited. * Recurrent or metastatic adenoid cystic carcinoma with evidence of disease progression (imaging progression or clinical evidence of progression) within one year of histological or cytological diagnosis. * Estimated survival \>12 weeks, as determined by the investigator. * The United States Eastern Cancer Consortium (ECOG) physical status score 0-1. * Has adequate organ function. * At least 1 measurable tumor lesion according to RECISTv1.1 criteria. Exclusion Criteria: * Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment. * Received prior therapies targeting HDAC. * Chemotherapy was received within 21 days before the first administration of the study treatment, and anti-tumor therapy such as radiotherapy, biotherapy, targeted therapy, and immunotherapy was received within 28 days before the first administration of the study treatment \[small molecule targeted drugs, Chinese medicines with anti-tumor indications, and local palliative radiotherapy were 14 times before the first administration of the study drug. * Used strong CYP3A4 inhibitors or inducers within 7 days before the first use of the investigational drug. * Major surgery or major injury \<=28 days before the first dose of study treatment,or anticipated major surgery during the study. * Prior allogeneic bone marrow transplantation or other solid organ transplantation * Active infection requiring systemic treatment. * Current or past presence of other malignancies (other than adequately treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix), unless radical treatment has been performed and there is no evidence of recurrence and metastasis in the last 5 years. * A person is known to be allergic to any active ingredient or excipient of the investigational drug. * Pregnant or lactating women. * patients with drug abuse or chronic alcohol abuse that may affect the evaluation of the test results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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.

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  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

  • Shanghai Oriental Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

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