New experimental pill takes on tough cancers

NCT ID NCT04390737

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental drug called HH2853 in people with certain types of blood cancer (non-Hodgkin lymphoma) or advanced solid tumors that have come back or stopped responding to treatment. The drug is taken as a tablet twice a day. The main goals are to find the safest dose and to see if the drug can shrink tumors. About 254 adults will take part across multiple hospitals.

What this could mean

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

Active substance
HH2853 (an experimental drug taken as a tablet)
What this could lead to
If it works, this could point toward a new treatment option for people with certain blood cancers or advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early, first-in-human study, so the drug may not work or may cause unexpected side effects. The trial is small and focused on finding the right dose, not proving a cure.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 254 people

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

Started

Sep 2020

Expected to finish

Dec 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: 1. Provided signed written informed consent prior to initiation of any study-related procedures; 2. Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age); 3. Tumor type criteria: The specific requirements for specific subtypes of recurrent/refractory non Hodgkin's lymphoma (NHL) confirmed by histology are as follows: Histologically confirmed follicular lymphoma (FL) that has been treated with at least two lines of systemic therapy (at least one regimen based on anti-CD20 monoclonal antibodies) according to GELF criteria or as determined by researchers (Grade 1-3a); Relapsed/refractory diffuse large B-cell lymphoma - non-specific (DLBCL NOS, 2016 World Health Organization Lymphoma Classification) that has received at least two treatment regimens in the past (at least one with CD20 monoclonal antibody as the main treatment, with a maximum number of treatment lines\<5), and is not a candidate for salvage treatment or autologous/allogeneic stem cell transplantation. Relapsed/refractory clinicopathologically documented PTCL with at least 1 line of prior systemic treatment (maximum \<5 lines). Solid tumors that meet the following criteria: 1. Histologically or cytologically documented advanced recurrent or metastatic solid tumor. 2. Phase I dose escalation: Measurable or evaluable lesions by RECIST v1.1 in at least 1 site; phase I dose extension and phase II: Measurable target lesions by RECIST v1.1 in at least 1 site. (Lesions that have been treated with radiotherapy or other local treatment are generally considered unmeasurable unless there is definite progression of the lesion.) 3. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. One of the following criteria should be met. Patients must experience at least one prior standard therapy. Disease progression occurred on or after last line of therapy, or intolerant to last line of therapy (maximum ≤3 lines, Patients without treatment options available known to provide clinical benefit are also eligible upon agreement from investigator and sponsor) There is no approved therapy, or for which standard therapy is unsuitable or refused by patients after being fully informed. For epithelioid sarcoma in Phase I and Phase II cohort 2: 1. Confirmed by local histology or cytology 2. Patients with unresectable locally delayed or metastatic epithelioid sarcoma who have undergone treatment (including those who have failed treatment and developed intolerable toxicity). For solid tumors in Phase I and Phase II queue 3: 1. Confirmed by local pathology as advanced recurrent or metastatic solid tumor. 2. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1; 5. Availability of archival tissue within three years 6. Relapsed/Refractory FL, Epithelioid sarcoma, relapsed/refractory PTCL, other relapsed/refractory non-Hodgkin's lymphomas with EZH2 mutation, and advanced solid tumors with specific genetic alterations, including EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation, or/and SMARCA4 mutation 7. Predicted life expectancy of ≥ 3 months; 8. Patient must meet the following laboratory values: 1.Serum total Bilirubin ≤ 1.5 x ULN or ≤ 3.0 mg/dL for patients with Gilbert's syndrome 2.AST/SGOT and ALT/SGPT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present 3.24-hour creatinine clearance (calculated\* or measured value\*\*)≥ 50 mL/min 4.Platelets ≥ 1 x LLN (no Platelet transfusion for 7 days prior to screening) 5.Hemoglobin (Hgb) ≥ 9 g/dL 6.Absolute Neutrophil Count (ANC) ≥ 1.0 x 10\^9/L 7.Adequate coagulation function: International normalized ratio (INR) \<1.3 (or \<3.0 on anticoagulants) 9. Measurable lesion Exclusion Criteria: 1. Any cancer-directed therapy within 28 days or five half-lives prior to first dose; Small molecule anticancer therapy within 2 weeks or five half-lives; Local radiotherapy within 14 days of first dose. 2. Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease. 3. Patients with prior transplant are excluded; 4. Major surgery within 4 weeks prior to first dose; 5. A prohibited medication or expected to require any of these medications during treatment with study drug within 2 weeks of first dose; 6. HIV (human immunodeficiency virus) infection, active hepatitis B or hepatitis C patients (HBsAg positive patients with HBV (hepatitis B virus) DNA ≥ 10\^3 copies or ≥ 200 IU/mL; HCV antibody test results are positive, and HCV (hepatitis C virus) RNA PCR test results are positive). 7. Concomitant malignancies or previous malignancies 8. Concurrent use of therapeutic warfarin is allowed. However, anticoagulants that do not have reversal agents available are prohibited except low molecular weight heparin and direct oral anticoagulants. 9. Any toxicities from prior treatment that have not recovered to ≤ CTCAE Grade 1 10. There were ≥ 3 lesions with punctate bleeding, any active bleeding, intratumoral bleeding, known bleeding tendencies, or treatment with antiplatelet/antithrombotic drugs. 11. Gastrointestinal condition which could impair absorption of study medication; 12. Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol; 13. Cardiac exclusion criteria: 1.History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 3 months prior to first dose of study drug; 2.Fridericia's corrected QT interval (QTcF) \> 450 ms (for male) and \> 470 ms (for female) on ECG conducted during screening; 3.Congenital long QT syndrome, or any known history of torsade de pointes (TdP), or family history of unexplained sudden death; 4.History or current evidence of serious uncontrolled ventricular arrhythmias; 5.Symptomatic congestive heart failure (Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system) within the previous 3 months; 6.Left ventricular ejection fraction (LVEF) \< 50%; 14. Any evidence of serious active infections requiring antibiotics; 15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or their excipients; 16. Pregnant or breast-feeding female; 17. Contraception: 18. Other serious illness or medical conditions at the Investigator's discretion, that may influence study results 19. Previously received treatment with EZH2 or EZH1/2 inhibitors. 20. Grade 3b FL or evidence of transformation to invasive lymphoma

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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

    21 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

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    RECRUITING

    Nanjing, Jiangsu, China

  • Affiliated Tumor Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, China

  • Beijing Jishuitan Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Liaoning Cancer Hospital&Institute

    RECRUITING

    Shenyang, Liaoning, China

  • Linyi Tumor Hospital

    RECRUITING

    Linyi, Shandong, China

  • Mayo Clinic

    COMPLETED

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    COMPLETED

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    COMPLETED

    Rochester, Minnesota, 55905, United States

  • NEXT Oncology

    COMPLETED

    San Antonio, Texas, 78240, United States

  • Shanghai Sixth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, China

  • Shengjing Hospital Of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • Sun Yat-Sen University Cancer Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Sun Yat-Sen University Cancer Hospital

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • Tianjin Cancer Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

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

    RECRUITING

    Wuhan, Hubei, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

  • Zhongshan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, China

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