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HH2853 for Non-Hodgkin's Lymphoma

Phase 1 & 2
Recruiting
Research Sponsored by Haihe Biopharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relapsed/refractory clinicopathologically documented PTCL with at least 1 line of prior systemic treatment (maximum <5 lines)
Solid tumors that are histologically or cytologically documented advanced recurrent or metastatic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28-day treatment cycles
Awards & highlights

Study Summary

This trial will test a new drug, HH2853, given orally twice a day for 28 days continuously. The trial has 3 parts: testing different doses of the drug (phase I), testing how well the drug works (phase II), and testing the drug in different populations (phase I dose extension).

Who is the study for?
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.Check my eligibility
What is being tested?
HH2853 Tablets are being tested for safety and effectiveness against various cancers. This trial has three parts: an initial phase to find the right dose, an extension of that phase, and a second phase for further evaluation. The drug is taken orally twice daily in continuous 28-day cycles.See study design
What are the potential side effects?
While the specific side effects of HH2853 are not listed here, common side effects from similar cancer medications can include nausea, fatigue, diarrhea, risk of infection due to lowered blood counts, liver function changes, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My PTCL has returned or didn't respond after 1 to 4 treatments.
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My cancer is advanced, recurrent, or has spread to other parts.
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My follicular lymphoma has been treated at least twice but no more than five times, and there are no other treatment options available.
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My condition cannot be treated with surgery, radiation, or combined therapy aimed at a cure.
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My diffuse large B-cell lymphoma has returned or didn't respond to treatment, and I've tried at least 2 treatments without success.
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My cancer has returned or didn't respond to treatment and has specific genetic changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28-day treatment cycles
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28-day treatment cycles for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events assessed according to NCI-CTCAE V5.0
Dose limiting toxicities (DLT)
Maximum tolerated Dose (MTD)
+2 more
Secondary outcome measures
AUCinf
AUClast
CL/F
+10 more
Other outcome measures
Biomarker Status
Change in tri-methylation of Histone H3K27 (H3K27me3)
Overall survival (ORR）
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: HH2853 administered on a BID schedule in continuous 28-day treatment cyclesExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Haihe Biopharma Co., Ltd.Lead Sponsor
16 Previous Clinical Trials
1,628 Total Patients Enrolled
Fugen LiStudy DirectorHaihe Biopharma Co., Ltd.

Media Library

HH2853 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04390737 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: HH2853 administered on a BID schedule in continuous 28-day treatment cycles
Non-Hodgkin's Lymphoma Clinical Trial 2023: HH2853 Highlights & Side Effects. Trial Name: NCT04390737 — Phase 1 & 2
HH2853 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04390737 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What key goals is this medical experiment attempting to accomplish?

"The central purpose of this 28-day long experiment is to determine the Recommended Phase II Dose (RP2D). Secondary objectives include characterizing the pharmacokinetic profile of HH2853 by measuring Terminal Half Life (T1/2), Area Under Curve Infinite Time (AUCinf) and Distribution Volume Fraction at Steady State (Vz/F)."

Answered by AI

What is the current scale of participation in this experiment?

"Affirmative. Per clinicaltrials.gov, this research project is presently seeking participants; it was first shared on September 8th 2020 and last updated on May 7th 2022. The study aims to enrol 188 individuals between four separate institutions."

Answered by AI

Are there any North American medical centers conducting this research endeavor?

"Currently, there are 4 sites that offer this research trial. The cities of San Antonio, Phoenix and Rochester have been selected in addition to another undisclosed medical centre. To reduce travel demands for participants, it is wise to choose the closest study site when enrolling."

Answered by AI

Is the study accepting new participants?

"Indeed, the information on clinicaltrials.gov reveals that this medical experiment is actively recruiting individuals. The trial was first publicized on September 8th 2020 and has been updated recently on May 7th 2022. This study requires 188 people to be recruited from 4 distinct research facilities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluate the Safety and Clinical Activity of HH2853
2020. "Evaluate the Safety and Clinical Activity of HH2853". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04390737.
~51 spots leftby Dec 2025
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