HH2853 for Non-Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, it mentions that any cancer-directed therapy should be stopped at least 28 days before the first dose, and certain medications are prohibited within 2 weeks of starting the trial.
What data supports the effectiveness of the drug HH2853 for treating non-Hodgkin's lymphoma?
Who Is on the Research Team?
Fugen Li
Principal Investigator
Haihe Biopharma Co., Ltd.
Are You a Good Fit for This Trial?
Adults with certain types of non-Hodgkin's lymphoma or advanced solid tumors who have relapsed or are not responding to treatment. Participants must be in good physical condition (ECOG ≤1), able to provide consent, and have a life expectancy over 3 months. They should not have had recent cancer treatments, major surgeries, or active infections and must meet specific lab values.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Dose Escalation
Accelerated titration with Bayesian Optimal Interval design to assess DLT, safety, tolerability, and establish MTD/RP2D
Phase I Dose Extension
Further evaluation of tolerability, pharmacokinetics, and efficacy at safe doses
Phase II
Evaluation of clinical activity in specific patient cohorts with relapsed/refractory conditions or genetic alterations
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HH2853
Find a Clinic Near You
Who Is Running the Clinical Trial?
Haihe Biopharma Co., Ltd.
Lead Sponsor