Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test

NCT ID NCT04977167

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 running a Phase I trial of HG146, an experimental oral drug, in adults with advanced solid tumors or lymphoma that have worsened despite standard treatments. The study first tests HG146 alone to find a safe dose, then tests it combined with a PD-(L)1 antibody, a type of immunotherapy. The main goals are to measure side effects, determine the highest dose people can tolerate, and see whether the drug shows any early signs of shrinking tumors. About 96 participants will take part across dose-finding and expansion groups.

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 oral cancer drug, tested alone and with a PD-(L)1 antibody
What this could lead to
If HG146 proves safe and shows signs of activity, it could become a new oral option for people whose advanced solid tumors or lymphoma have stopped responding to other treatments.
What could go wrong
This is a small, early-stage Phase I trial focused mainly on safety and dosing, so it may not show meaningful benefit. HG146 could cause side effects that limit its use, and combining it with a PD-(L)1 inhibitor may not improve outcomes.

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

24 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2024

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.

Key Inclusion Criteria: 1 Subject must be \>=18 years of age at the time of signing the informed consent. 2- Ia/Ib dose escalation phase(Part1 and Part 2A):Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established. * Ib dose expansion phase(Part 2): 1. Cohort 1,Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established, have not been treated with PD-(L)1 antibody; 2)Cohort 2,Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established, have progressed on PD-(L)1 antibody; 3 Measurable disease per RECIST version 1.1 or Lugano 2014(If applicable). 4 Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1. 5 Has adequate organ function. 6 Signed informed consent form (ICF) and able to comply with study requirements. Key Exclusion Criteria: 1. Received prior therapies targeting HDAC. 2. Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment. 3. History of intolerant of anti-PD-(L)1 toxicity(Ib). 4. A condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of enrollment. 5. Major surgery or major injury \<=28 days before the first dose of study treatment,or anticipated major surgery during the study. 6. Received other anticaner therapies within 4 weeks prior to first dose of study treatment or 5 half life period of anticancer drug . 7. Active infection requiring systemic treatment. 8. Prior allogeneic bone marrow transplantation or other solid organ transplantation ( Ib) 9. Active autoimmune disease or disease of impaired immune system(Ib). 10. History of Adrenal insufficiency.(Ib) 11. History orConcurrent condition of other malignant tumors. 12. Recent (within the past 6 months) history of Unstable or serious diseases, such as pancreatitis, severe angina, prolonged QT interval, congestive heart failure, myocardial infarction, pulmonary hypertension, stroke, and severe seizures, etc. 13. History of severe lung disease. 14. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.

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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.

Contacts and locations

Locations

  • National Cancer Center/Cancer Hospital

    Beijing, China

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Other studies related to the condition(s) this trial covers.