Please sign in to follow a disease.
Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
NCT ID NCT04977167
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Oral drug that targets two cancer drivers tested in first human study
- Mitochondria-Targeting drug gamitrinib tested for first time in humans
- Can a Two-Drug combo outsmart advanced cancer?
- Reprogrammed immune cells target CD30-Positive lymphoma in early trial
- New injectable drug tested for safety in Hard-to-Treat solid tumors
- New antibody drug conjugate tested against advanced cancers