HMPL-523 for Lymphoma

Recruiting at 32 trial locations

Overseen By Rathi Pillai, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hutchison Medipharma Limited

Must not be taking: SYK inhibitors, Strong CYP3A inhibitors

Disqualifiers: CNS lymphoma, Second primary tumors, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot have had any anticancer therapy within 3 weeks, herbal therapy within 1 week, or use certain medications affecting liver enzymes within 7 days before starting the study treatment.

What makes the drug HMPL-523 unique for treating lymphoma?

HMPL-523 (Sovleplenib) is unique because it targets specific pathways involved in lymphoma cell growth, potentially offering a more targeted approach compared to traditional chemotherapy regimens like CHOP, which use a combination of drugs to kill cancer cells. This targeted mechanism may result in fewer side effects and improved effectiveness for certain lymphoma subtypes. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a Phase I, open-label, multicenter study of HMPL-523 administered orally to patients with relapsed or refractory lymphoma who have exhausted approved therapy options. This study consists of a dose escalation stage (Stage1) and a dose expansion stage (Stage 2).

Research Team

Vijay Jayaprakash, MD

Principal Investigator

Hutchmed

Eligibility Criteria

Adults over 18 with lymphoma that's come back or hasn't responded to treatment can join this trial. They should be relatively healthy (ECOG status of 0 or 1), have a life expectancy over 24 weeks, and agree to use effective birth control. People with certain blood counts, organ dysfunction, recent other treatments, or serious health issues like heart failure aren't eligible.

Inclusion Criteria

My cancer is a type of lymphoma, possibly including Hodgkin's or non-Hodgkin's.

I agree to use effective birth control during and for 30 days after the study.

I can provide a tumor sample from after my last treatment or get a new biopsy.

Exclusion Criteria

Pregnant (positive serum beta human chorionic gonadotropin test) or lactating women

I am currently taking medication that affects my heart's rhythm.

If you have any other medical conditions or test results that make the doctor think it's not safe for you to take the experimental drug, you won't be able to participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive HMPL-523 in escalating doses to determine the maximum tolerated dose

28 days per cycle

Continuous monitoring during each cycle

Dose Expansion

Participants receive HMPL-523 at the maximum tolerated dose to evaluate safety and preliminary efficacy

28 days per cycle until disease progression or other criteria

Continuous monitoring during each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HMPL-523

Trial Overview The trial is testing HMPL-523, an oral medication for patients with relapsed/refractory lymphoma. It has two parts: first finding the right dose (Stage 1) and then seeing how well it works at that dose in more people (Stage 2).

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

All patients to received study drug (HMPL-523)

HMPL-523 is already approved in China for the following indications:

Approved in China as Sovleplenib for:

• Immune thrombocytopenic purpura (ITP)

Who Is Running the Clinical Trial?

Hutchison Medipharma Limited

Lead Sponsor

Trials

104

Recruited

14,000+

Dr. Weiguo Su

Hutchison Medipharma Limited

Chief Executive Officer since 2022

PhD in Chemistry from Harvard University, BSc in Chemistry from Fudan University

Dr. Karen Atkin

Hutchison Medipharma Limited

Chief Medical Officer since 2023

MD from Harvard Medical School

Hutchmed

Lead Sponsor

Trials

38

Recruited

6,700+

Findings from Research

Mantle cell lymphoma (MCL) has historically had poorer treatment outcomes compared to other non-Hodgkin's lymphoma subtypes, with many patients being ineligible for intensive therapies due to age and health conditions.

Current research is focusing on developing targeted therapies, such as the mTOR inhibitor temsirolimus and combination regimens with bortezomib, to improve treatment efficacy while minimizing side effects for patients with relapsed MCL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of targeted therapies for mantle cell lymphoma. Chang, JE., Kahl, BS.[2021]

References

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

A dose-finding study of liposomal daunorubicin with CVP (COP-X) in advanced NHL. [2020]

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

VP-16 in the treatment of malignant lymphomas: a report from the Swiss Group for Clinical Cancer Research (SAKK). [2013]

3. England pubmed.ncbi.nlm.nih.gov

Use of bortezomib in B-cell non-Hodgkin's lymphoma. [2015]

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

Recent advances in the treatment of mantle cell lymphoma: a post-ASH 2009 discussion. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Current status of targeted therapies for mantle cell lymphoma. [2021]