NCT04390737 · Haihe Biopharma Co., Ltd.
Evaluate the Safety and Clinical Activity of HH2853
What this study is about
This is an where both patients and doctors know the treatment given, conducted at multiple hospitals, first-in-human phase I/II study which is composed of 3 parts: phase I gradually increasing doses, phase I dose extension and phase II. HH2853 will be administered taken by mouth on a continuous BID schedule on a continuous 28-day treatment cycle.
View original scientific description
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.
Interventions
DRUG
HH2853 Tablets
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 candidat
Where
- Phoenix, Arizona
- Jacksonville, Florida
- Rochester, Minnesota
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations