FL LymphomaPhase 1/2NCT04390737
Evaluate the Safety and Clinical Activity of HH2853
A Phase 1/2 study testing HH2853 Tablets in people with FL Lymphoma and Epithelioid Sarcoma, run by Haihe Biopharma Co., Ltd. at 25 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- FL Lymphoma, Epithelioid Sarcoma, Peripheral T Cell Lymphoma
- What is being tested?
- HH2853 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 8 Sep 2020to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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 join
- 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.
- Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
- 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;
- 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).
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- Concomitant malignancies or previous malignancies
- 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.
- 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
Trial locations and contacts
25 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 2 countries
China21 sites, 21 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, linshenpku@163.com
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Jun Zhu, zhujun3346@163.com
Yuqin Song, songyuqin622@163.com
- Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality
Xiaohui Niu, niuxiaohui@263.net
- Recruiting
Beijing Cancer Hospital
Beijing
Zhengfu Fan, zhengfufan@126.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Hui Zhou, Zhouhui9403@126.com
Xianan Li
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Lijun Zou, hxlcyxy@163.com
Yu Jiang
- Recruiting
Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong
Zhiming Li, lizhm@sysucc.org.cn
Jundong Li
- Recruiting
Sun Yat-Sen University Cancer Hospital
Guangzhou
Jin Wang, wangjinr@sysucc.org.cn
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Meiyu Fang, fangmy@zjcc.org.cn
Haiyan Yang
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Kangsheng Gu, 13805692145@163.com
- Recruiting
Linyi Tumor Hospital
Linyi, Shandong
Zhen Wang, LYSZLYYNSK@163.com
- Recruiting
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu
Tianru Li, li_rutian@163.com
- Recruiting
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi
Hong Cen, cen_hong@163.com
Weimin Xie
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
Yang Dong, dongyang6405@163.com
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality
Yuhong Zhou, zhou.yuhong@zs-hospital.sh.cn
- Recruiting
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning
Xiaojing Zhang, Zhangxiaojingwu@163.com
- Recruiting
Shengjing Hospital Of China Medical University
Shenyang, Liaoning
Wei Yang, sjyangw@163.com
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi
Yuxia Shi, 1274174089@qq.com
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality
Shiyong Zhou, zsy1003@163.com
Jilong Yang
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Liling Zhang, zlladct@163.com
Jing Chen
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Keshu Zhou, drzhouks77@163.com
Weitao Yao, ywtwhm@163.com
United States4 sites
- Completed
Mayo Clinic
Jacksonville, Florida, 32224
- Completed
Mayo Clinic
Phoenix, Arizona, 85054
- Completed
Mayo Clinic
Rochester, Minnesota, 55905
- Completed
NEXT Oncology
San Antonio, Texas, 78240
About this study
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
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.
Read the detailed description
Phase I:
Phase I dose escalation The accelerated titration (ATD) incorporated with Bayesian Optimal Interval design (BOIN) will be used to assess the DLT, safety, tolerability, MTD and furthermore, to establish the RP2D. DLT assessment is only applicable to phase I dose escalation.
Eligible patients will be enrolled in the ascending dose until MTD/RP2D is established.
Phase I dose extension During the dose escalation phase, a dose extension with additional patients will be included in order to further evaluate the tolerability, pharmacokinetics, and efficacy at doses that have been evaluated as safe. The number of patients to be enrolled in each dose extension cohort is up to 15, but the final number of dose level can be determined and the final patient number at each dose level can be adjusted slightly based on available safety, efficacy, PK, and PD data upon agreement from sponsor and investigators (e.g. safety evaluation meeting). For phase I dose extension, approximately 30 patients will be enrolled based on initial estimate, but the final total number of patients will depend on the number of dose levels extended and patient number at each dose level.
The total number of patients is estimated to be approximately 60 patients for phase I dose escalation and dose extension, but the final total number of patients will depend upon the number of dose cohorts to reach MTD/RP2D, and patient number at each dose level.
Phase II（China Only）:
Phase II is planned after the completion of phase I. Up to approximately 193 patients will be enrolled as outlined below:
- Cohort 1: Relapsed/Refractory FL (n≈56)
- Cohort 2: Epithelioid sarcoma (n≈77)
- Cohort 3: Relapsed/Refractory PTCL, other relapsed/refractory Non-Hodgkin's lymphomas with EZH2 mutation, or advanced solid tumors with specific genetic alterations, including EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation, or/and SMARCA4 mutation (n≈60)
- Being tested
- HH2853 Tablets
- Keywords
- Phase I/II, HH2853, PRC2, EZH 1/2 inhibitor
- Medical subject headings
- Lymphoma, Follicular, Sarcoma, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH2853 TabletsDrug
Proposed daily dose (BID): 50mg, 100mg, 200mg, 400mg, 600mg, 800mg, 1000mg. It is possible for additional and/or intermediate dose levels to be added during the course of the study. Cohorts may be added at any dose level below the MTD in order to better understand safety, PK or PD.
| Study group | Role | What they receive |
|---|---|---|
| HH2853 administered on a BID schedule in continuous 28-day treatment cycles | Experimental | 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. Receives: Drug: HH2853 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated Dose (MTD)
Determine MTD of HH2853
Measured: 28-day treatment cycles
Recommended phase II dose (RP2D)
Determine RP2D of HH2853
Measured: 28-day treatment cycles
Adverse events assessed according to NCI-CTCAE V5.0
Evaluate the safety of HH2853
Measured: 28-day treatment cycles
Dose limiting toxicities (DLT)
Evaluate the tolerability of HH2853
Measured: 28-day treatment cycles
Objective response rate (ORR）
Assess the preliminary efficacy of HH2853
Measured: 28-day treatment cycles
Secondary outcomes (13)
AUClast
Characterize the pharmacokinetic profile of HH2853
Measured: 28-day treatment cycles
AUCinf
Characterize the pharmacokinetic profile of HH2853
Measured: 28-day treatment cycles
Cmax
Characterize the pharmacokinetic profile of HH2853
Measured: 28-day treatment cycles
Tmax
Characterize the pharmacokinetic profile of HH2853
Measured: 28-day treatment cycles
CL/F
Characterize the pharmacokinetic profile of HH2853
Measured: 28-day treatment cycles
Vz/F
Characterize the pharmacokinetic profile of HH2853
Measured: 28-day treatment cycles
Terminal half-life (T1/2)
Characterize the pharmacokinetic profile of HH2853
Measured: 28-day treatment cycles
Duration of response (DoR)
Assess the preliminary efficacy of HH2853
Measured: 28-day treatment cycles
Progression-free survival (PFS)
Assess the preliminary efficacy of HH2853
Measured: 28-day treatment cycles
Disease control rate (DCR)
Assess the preliminary efficacy of HH2853
Measured: 28-day treatment cycles
Time to response (TTR)
Assess the preliminary efficacy of HH2853
Measured: 28-day treatment cycles
Time to progression (TTP)
Assess the preliminary efficacy of HH2853
Measured: 28-day treatment cycles
Clinical Outcome
Explore the association between potential biomarker and the clinical outcome
Measured: 28-day treatment cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start8 Sep 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FL LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haihe Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fugen Li, Study director, Haihe Biopharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390737
- Sponsor's protocol ID
- HH2853-G101
- Status last verified
- Jan 2026
- First submitted
- 6 May 2020
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in China, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.haihepharma.com/
Publications
Fan Z, Wang J, Liu D, Shen L, Fang M, Johnson P, Tun H, Sommerhalder D, Yang J, Yang Y, Munozi J, Zhu J, Gao T, Li Z, Li X, Ma Q, Lv C, Yu S, Li F, Song Y, Gong J. Safety and efficacy of HH2853, a novel EZH1/2 dual inhibitor, in patients with refractory solid tumours or non-Hodgkin lymphomas: a phase I study. EClinicalMedicine. 2025 Aug 7;86:103398. doi: 10.1016/j.eclinm.2025.103398. eCollection 2025 Aug.
PubMed 40821900Hong H, Chen Z, Zhang M, Peng Z, Shen J, Shuang Y, Zhou H, Guo H, Huang H, Li F, Qian Z, Liu L, Wang L, Yang W, Zhang L, He P, Qian S, Li F, Li M, Lin T. A multicenter, open-label, single-arm, phase Ib clinical trial of HH2853 treatment in patients with relapsed and/or refractory peripheral T-cell lymphoma. J Hematol Oncol. 2025 Apr 27;18(1):50. doi: 10.1186/s13045-025-01697-z.
PubMed 40289142
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04390737
- Acronym / sponsor ID
- HH2853-G101
- Keywords
- Phase I/II, HH2853, PRC2, EZH 1/2 inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Haihe Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase I:
Phase I dose escalation The accelerated titration (ATD) incorporated with Bayesian Optimal Interval design (BOIN) will be used to assess the DLT, safety, tolerability, MTD and furthermore, to establish the RP2D. DLT assessment is only applicable to phase I dose escalation.
Eligible patients will be enrolled in the ascending dose until MTD/RP2D is established.
Phase I dose extension During the dose escalation phase, a dose extension with additional patients will be included in order to further evaluate the tolerability, pharmacokinetics, and efficacy at doses that have been evaluated as safe. The number of patients to be enrolled in each dose extension cohort is up to 15, but the final number of dose level can be determined and the final patient number at each dose level can be adjusted slightly based on available safety, efficacy, PK, and PD data upon agreement from sponsor and investigators (e.g. safety evaluation meeting). For phase I dose extension, approximately 30 patients will be enrolled based on initial estimate, but the final total number of patients will depend on the number of dose levels extended and patient number at each dose level.
The total number of patients is estimated to be approximately 60 patients for phase I dose escalation and dose extension, but the final total number of patients will depend upon the number of dose cohorts to reach MTD/RP2D, and patient number at each dose level.
Phase II（China Only）:
Phase II is planned after the completion of phase I. Up to approximately 193 patients will be enrolled as outlined below:
- Cohort 1: Relapsed/Refractory FL (n≈56)
- Cohort 2: Epithelioid sarcoma (n≈77)
- Cohort 3: Relapsed/Refractory PTCL, other relapsed/refractory Non-Hodgkin's lymphomas with EZH2 mutation, or advanced solid tumors with specific genetic alterations, including EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation, or/and SMARCA4 mutation (n≈60)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HH2853 administered on a BID schedule in continuous 28-day treatment cycles | Experimental | Drug: HH2853 TabletsHH2853 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HH2853 TabletsProposed daily dose (BID): 50mg, 100mg, 200mg, 400mg, 600mg, 800mg, 1000mg. It is possible for additional and/or intermediate dose levels to be added during the course of the study. Cohorts may be added at any dose level below the MTD in order to better understand safety, PK or PD. | Drug | HH2853 administered on a BID schedule in continuous 28-day treatment cycles |
Primary outcome
Maximum tolerated Dose (MTD)
Time frame: 28-day treatment cycles
Determine MTD of HH2853
Recommended phase II dose (RP2D)
Time frame: 28-day treatment cycles
Determine RP2D of HH2853
Adverse events assessed according to NCI-CTCAE V5.0
Time frame: 28-day treatment cycles
Evaluate the safety of HH2853
Dose limiting toxicities (DLT)
Time frame: 28-day treatment cycles
Evaluate the tolerability of HH2853
Objective response rate (ORR）
Time frame: 28-day treatment cycles
Assess the preliminary efficacy of HH2853
13 secondary outcomes
AUClast
Time frame: 28-day treatment cycles
AUCinf
Time frame: 28-day treatment cycles
Cmax
Time frame: 28-day treatment cycles
Tmax
Time frame: 28-day treatment cycles
CL/F
Time frame: 28-day treatment cycles
Vz/F
Time frame: 28-day treatment cycles
Terminal half-life (T1/2)
Time frame: 28-day treatment cycles
Duration of response (DoR)
Time frame: 28-day treatment cycles
Progression-free survival (PFS)
Time frame: 28-day treatment cycles
Disease control rate (DCR)
Time frame: 28-day treatment cycles
Time to response (TTR)
Time frame: 28-day treatment cycles
Time to progression (TTP)
Time frame: 28-day treatment cycles
Clinical Outcome
Time frame: 28-day treatment cycles
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 40821900Fan Z, Wang J, Liu D, Shen L, Fang M, Johnson P, Tun H, Sommerhalder D, Yang J, Yang Y, Munozi J, Zhu J, Gao T, Li Z, Li X, Ma Q, Lv C, Yu S, Li F, Song Y, Gong J. Safety and efficacy of HH2853, a novel EZH1/2 dual inhibitor, in patients with refractory solid tumours or non-Hodgkin lymphomas: a phase I study. EClinicalMedicine. 2025 Aug 7;86:103398. doi: 10.1016/j.eclinm.2025.103398. eCollection 2025 Aug.
- Derived from this study: PubMed 40289142Hong H, Chen Z, Zhang M, Peng Z, Shen J, Shuang Y, Zhou H, Guo H, Huang H, Li F, Qian Z, Liu L, Wang L, Yang W, Zhang L, He P, Qian S, Li F, Li M, Lin T. A multicenter, open-label, single-arm, phase Ib clinical trial of HH2853 treatment in patients with relapsed and/or refractory peripheral T-cell lymphoma. J Hematol Oncol. 2025 Apr 27;18(1):50. doi: 10.1186/s13045-025-01697-z.
- Individual participant dataSharing planned: Yes. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in China, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.haihepharma.com/
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Anaplastic Astrocytoma, Anaplastic Astrocytoma, Not Otherwise Specified
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fugen Li study director
Haihe Biopharma Co., Ltd.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HH2853 Tablets in people with FL Lymphoma and Epithelioid Sarcoma, run by Haihe Biopharma Co., Ltd. at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyue Chen (+86 21 20568888, haiyue.chen@haihepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated Dose (MTD) (time frame: 28-day treatment cycles). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04390737, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.