Tests HH2853 tablets in adults with relapsed lymphoma or advanced solid tumors
Tests HH2853 tablets in adults with relapsed lymphoma or advanced solid tumors.
Key facts
- Who runs it
- Haihe Biopharma Co., Ltd.
- Where
- Beijing, Changsha, Chengdu, Guangzhou, Hangzhou, Hefei, Linyi, Nanjing, Nanning, Shanghai, Shenyang, Taiyuan, Tianjin, Wuhan, and Zhengzhou, ChinaSee the 18 sitesAlso in 1 other country, 4 sites
- Trial code
- Registry title
- Evaluate the Safety and Clinical Activity of HH2853
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 254 people, planned
- Started
- 8 Sept 2020
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional
- Treatments tested
- HH2853 Tablets
- Record updated
- 30 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with relapsed or hard-to-treat follicular lymphoma, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, epithelioid sarcoma, or advanced solid tumors with certain gene changes.
- Age
- 18 years or older.
- Sex
- Men and women can join.
- Disease stage
- Relapsed or refractory non-Hodgkin's lymphoma (follicular, diffuse large B-cell, peripheral T-cell), or advanced, recurrent or metastatic solid tumor, including epithelioid sarcoma, that cannot be treated with surgery or radiation to remove all of the disease.
- Earlier treatment
- Follicular lymphoma: at least 2 lines of systemic treatment. Diffuse large B-cell lymphoma: at least 2 treatment regimens (fewer than 5 lines). Peripheral T-cell lymphoma: at least 1 line (fewer than 5). Solid tumors: at least 1 standard treatment (maximum 3 lines), or no approved treatment exists. Earlier treatment with EZH2 or EZH1/2 inhibitors is not allowed.
- Biomarker or test result
- Gene change such as EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation or SMARCA4 mutation, for the follicular lymphoma, other lymphoma and solid tumor groups. Epithelioid sarcoma is also named as a group.
Main reasons for not taking part
- Any cancer treatment within 28 days or five half-lives before the first dose
- Symptomatic brain or spinal cord metastases that are unstable
- Earlier organ or tissue transplant
- HIV infection, or active hepatitis B or hepatitis C
- Pregnant or breast-feeding women
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- Provided signed written informed consent prior to initiation of any study-related procedures
- Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age)
- 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:
- Histologically or cytologically documented advanced recurrent or metastatic solid tumor
- 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.)
- 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:
- Confirmed by local histology or cytology
- 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:
- Confirmed by local pathology as advanced recurrent or metastatic solid tumor
- 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
Who cannot take part
- 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
- Patients with prior transplant are excluded
- Major surgery within 4 weeks prior to first dose
- A prohibited medication or expected to require any of these medications during treatment with study drug within 2 weeks of first dose
- 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
- Any toxicities from prior treatment that have not recovered to ≤ CTCAE Grade 1
- There were ≥ 3 lesions with punctate bleeding, any active bleeding, intratumoral bleeding, known bleeding tendencies, or treatment with antiplatelet/antithrombotic drugs
- Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease
- 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)
- Concomitant malignancies or previous malignancies
- Gastrointestinal condition which could impair absorption of study medication
- Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol
- 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
Where in China
Also in 1 other country, 4 sites
- Beijing Cancer HospitalBeijing, ChinaContact: Lin ShenTaking people
- Beijing Jishuitan HospitalBeijing, ChinaContact: Xiaohui NiuTaking people
- Hunan Cancer HospitalChangsha, ChinaContact: Hui ZhouTaking people
- West China Hospital of Sichuan UniversityChengdu, ChinaContact: Lijun ZouTaking people
- Sun Yat-sen University Cancer HospitalGuangzhou, ChinaContact: Zhiming LiTaking people
- Zhejiang Cancer HospitalHangzhou, ChinaContact: Meiyu FangTaking people
- The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaContact: Kangsheng GuTaking people
- Linyi Tumor HospitalLinyi, ChinaContact: Zhen WangTaking people
- Affiliated Drum Tower Hospital, Medical School of Nanjing UniversityNanjing, ChinaContact: Tianru LiTaking people
- Affiliated Tumor Hospital of Guangxi Medical UniversityNanning, ChinaContact: Hong CenTaking people
- Shanghai Sixth People's HospitalShanghai, ChinaContact: Yang DongTaking people
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaContact: Yuhong ZhouTaking people
- Liaoning Cancer Hospital & InstituteShenyang, ChinaContact: Xiaojing ZhangTaking people
- Shengjing Hospital Of China Medical UniversityShenyang, ChinaContact: Wei YangTaking people
- Shanxi Cancer hospitalTaiyuan, ChinaContact: Yuxia ShiTaking people
- Tianjin Cancer HospitalTianjin, ChinaContact: Shiyong ZhouTaking people
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: Liling ZhangTaking people
- Henan Cancer HospitalZhengzhou, ChinaContact: Keshu ZhouTaking people
About the trial
What the trial wants to find out
This is an open-label, multicenter, first-in-human phase I/II study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.
The group in the trial
- HH2853 administered on a BID schedule in continuous 28-day treatment cyclesTreatment being tested
HH2853 is supplied as tables with dosage strength of 25mg and 200mg. HH2853 Tablet will be administered orally on a continuous twice daily (BID) schedule, on a flat scale of mg and not individually adjusted by weight or body surface area. A treatment cycle is defined as 28 days for the purposes of scheduling procedures and evaluations. All patients will be treated with HH2853 orally on a continuous BID schedule, beginning on Cycle 1 Day 1. But patients in accelerated titration (ATD) part should be administered a single dose on the first day in order to evaluate the PK of a single dose administration. Dosing is twice daily from the second day thereafter.
Treatment: HH2853 Tablets
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of HH2853 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphomas or Advanced Solid Tumors
- Plain-language title
- Tests HH2853 tablets in adults with relapsed lymphoma or advanced solid tumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 30 January 2026