Actively Recruiting
Evaluate the Safety and Clinical Activity of HH2853
Led by Haihe Biopharma Co., Ltd. · Updated on 2026-01-30
254
Participants Needed
25
Research Sites
433 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluate the Safety and Clinical Activity of HH2853
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided signed written informed consent before any study procedures
- Male or female 18 years of age or older at the time of consent
- Histologically confirmed relapsed/refractory follicular lymphoma treated with at least two systemic therapies including anti-CD20 antibody, or relapsed/refractory diffuse large B-cell lymphoma treated with at least two regimens including CD20 antibody and unsuitable for transplant
- Relapsed/refractory peripheral T cell lymphoma with at least one prior systemic treatment
- Histologically or cytologically confirmed advanced recurrent or metastatic solid tumor not amenable to curative surgery or radiation
- Measurable or evaluable lesions by RECIST v1.1 in at least one site
- Disease progressed on or after last therapy or intolerant to last therapy with no approved or suitable standard options
- Confirmed unresectable or metastatic epithelioid sarcoma treated previously
- ECOG performance status 0 or 1
- Availability of archival tissue within three years
- Presence of specific genetic alterations including EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation, or SMARCA4 mutation
- Predicted life expectancy of at least 3 months
- Laboratory values within specified limits including bilirubin, liver enzymes, creatinine clearance, platelets, hemoglobin, neutrophil count, and coagulation function
- Measurable lesion present
You will not qualify if you...
- Any cancer-directed therapy within 28 days or five half-lives before first dose
- Small molecule anticancer therapy within 2 weeks before first dose
- Local radiotherapy within 14 days before first dose
- Symptomatic unstable CNS metastases or requiring increasing steroids
- History of transplant
- Major surgery within 4 weeks before first dose
- Use or expected need of prohibited medications within 2 weeks before first dose
- Active HIV, hepatitis B or C infection
- Concurrent malignancies or previous malignancies
- Use of anticoagulants without reversal agents except specified types
- Unresolved toxicities from prior treatment above grade 1
- Significant bleeding or bleeding disorders
- Gastrointestinal conditions impairing drug absorption
- Psychological, social, or geographic conditions limiting protocol compliance
- Cardiac conditions including recent acute coronary events, prolonged QT interval, arrhythmias, heart failure, or low ejection fraction
- Serious active infections requiring antibiotics
- Known hypersensitivity to study drug or excipients
- Pregnant or breastfeeding females
- Previous treatment with EZH2 or EZH1/2 inhibitors
- Grade 3b follicular lymphoma or transformation to invasive lymphoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Completed
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
Completed
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Completed
4
NEXT Oncology
San Antonio, Texas, United States, 78240
Completed
5
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
6
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
7
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
8
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
9
Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, China
Actively Recruiting
10
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Actively Recruiting
11
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
12
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
13
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
14
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
Actively Recruiting
15
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, China
Actively Recruiting
16
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
17
Linyi Tumor Hospital
Linyi, Shandong, China
Actively Recruiting
18
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
19
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
20
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Actively Recruiting
21
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
22
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
23
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
24
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
25
Sun Yat-Sen University Cancer Hospital
Guangzhou, China
Actively Recruiting
Research Team
H
Haiyue Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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