HH2853 for Non-Hodgkin's Lymphoma

Recruiting at 17 trial locations

Overseen By Haiyue Chen

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Haihe Biopharma Co., Ltd.

Must not be taking: Anticancer, Antiplatelet, Antithrombotic, others

Disqualifiers: CNS metastases, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

254 Participants Needed

Trial Summary

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?

The research highlights that high-grade non-Hodgkin's lymphomas respond well to chemotherapy, especially regimens containing doxorubicin, which is similar to the standard CHOP therapy. This suggests that treatments like HH2853, if similar, might also be effective. ^{1 2 3 4 5}

Research Team

Fugen Li

Principal Investigator

Haihe Biopharma Co., Ltd.

Eligibility Criteria

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

I have non-Hodgkin's lymphoma that has returned or didn't respond to treatment, and I've had 2-5 prior treatments.

My PTCL has returned or didn't respond after 1 to 4 treatments.

Provided signed written informed consent prior to initiation of any study-related procedures

Exclusion Criteria

I haven't had any cancer treatments recently.

I have not had major surgery recently.

My brain metastases are causing symptoms and need more medication to manage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Dose Escalation

Accelerated titration with Bayesian Optimal Interval design to assess DLT, safety, tolerability, and establish MTD/RP2D

28-day treatment cycles

Continuous monitoring during treatment cycles

Phase I Dose Extension

Further evaluation of tolerability, pharmacokinetics, and efficacy at safe doses

28-day treatment cycles

Continuous monitoring during treatment cycles

Phase II

Evaluation of clinical activity in specific patient cohorts with relapsed/refractory conditions or genetic alterations

28-day treatment cycles

Continuous monitoring during treatment cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HH2853

Trial Overview 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.

Participant Groups

Group I: HH2853 administered on a BID schedule in continuous 28-day treatment cycles Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Haihe Biopharma Co., Ltd.

Lead Sponsor

Trials

17

Recruited

1,900+

Findings from Research

In a study of 111 patients with advanced non-Hodgkin's lymphoma over 7 years, factors like a complete response to treatment, low serum LDH levels, and no liver involvement were linked to better long-term survival outcomes.

For patients who achieved a complete response, the specific subtype of lymphoma, particularly classified by the Kiel classification, was crucial in predicting longer relapse-free and overall survival, highlighting the need for tailored treatment strategies based on histology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multivariate analysis of factors affecting survival in patients with high-grade histology non-Hodgkin's lymphoma. Steward, WP., Todd, ID., Harris, M., et al.[2019]

High-grade non-Hodgkin's lymphomas (NHL) are aggressive and often present with extranodal disease, particularly in immunocompromised patients, but they respond well to chemotherapy and radiation.

The standard treatment for high-grade NHL is the CHOP regimen (doxorubicin, cyclophosphamide, oncovin, and prednisone), and factors like age, performance status, and disease stage are important for predicting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[High-grade non-Hodgkin lymphoma: diagnosis and therapy]. Trümper, L., Pfreundschuh, M.[2015]

Localized non-Hodgkin's lymphomas, even of aggressive types, are often more widespread than initially thought, necessitating systemic chemotherapy with doxorubicin to achieve high cure rates of about 95% for stage I and 75% for stage II patients.

Despite these high cure rates, up to 30% of patients still do not respond to treatment, highlighting the need for ongoing research to better understand the biology of non-Hodgkin's lymphomas and identify patients at risk of treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients with localized non-Hodgkin's lymphomas provide opportunities for future research. Miller, TP., Grogan, TM.[2015]

Hodgkin's lymphoma (HL) has become one of the most curable cancers in adults, with about 80% of patients achieving long-term disease-free survival due to substantial clinical advancements.

Current treatment strategies focus on enhancing chemotherapy and radiotherapy effectiveness while reducing side effects, with ongoing trials exploring lower doses and smaller radiation fields, as well as more intense drug combinations for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line treatment of Hodgkin's lymphoma. Klimm, B., Engert, A., Diehl, V.[2007]

Hodgkin lymphoma (HL) generally has a good prognosis with standard chemotherapy and radiation, but patients with relapsed or refractory disease face poorer outcomes, highlighting the need for new treatment options.

Novel therapies, including antibody-drug conjugates targeting CD30 and immune checkpoint inhibitors, are showing promise in treating HL, and ongoing trials are investigating their use in combination with existing chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel agents in the therapy of Hodgkin lymphoma. Ansell, S.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

A multivariate analysis of factors affecting survival in patients with high-grade histology non-Hodgkin's lymphoma. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[High-grade non-Hodgkin lymphoma: diagnosis and therapy]. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Patients with localized non-Hodgkin's lymphomas provide opportunities for future research. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

First-line treatment of Hodgkin's lymphoma. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Novel agents in the therapy of Hodgkin lymphoma. [2018]