HMPL-523 for Lymphoma

No longer recruiting at 36 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new oral medication called HMPL-523 (Sovleplenib) to determine its safety and effectiveness for people with various types of lymphoma, including Hodgkin's and non-Hodgkin's, who haven't had success with other treatments. In its early stages, the trial focuses on finding the right dose and understanding how the drug affects the body. It suits patients who have tried all approved therapies for their relapsed or stubborn lymphoma but still need a solution. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering patients the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that HMPL-523 is likely to be safe for humans?

Research has shown that HMPL-523, also known as sovleplenib, is generally safe for patients with certain health conditions. In studies involving patients with relapsed or hard-to-treat B-cell lymphoma, the treatment effectively combated the cancer while remaining safe for most patients. Reports from these studies indicate that patients generally tolerated the treatment well.

Additionally, for those with chronic primary immune thrombocytopenia (a condition where the immune system attacks blood platelets), HMPL-523 provided lasting benefits and was easy for patients to handle. This suggests it could be safe for use in other conditions, such as lymphoma. However, since this is an early study, participants should consult their healthcare providers about the possible risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HMPL-523 for treating lymphoma because it represents a new approach compared to typical chemotherapy and immunotherapy options. HMPL-523 specifically targets the spleen tyrosine kinase (SYK) pathway, which plays a crucial role in the survival and proliferation of lymphoma cells. By directly inhibiting this pathway, HMPL-523 could potentially offer a more precise treatment, reducing damage to healthy cells and potentially leading to fewer side effects. This novel mechanism of action distinguishes it from standard treatments and is why it's generating interest as a promising alternative for lymphoma patients.

What evidence suggests that HMPL-523 might be an effective treatment for lymphoma?

Research has shown that HMPL-523, also known as sovleplenib, may help treat lymphoma. One study found that 48% of patients responded well to the treatment, while none responded to a placebo, a fake treatment. This difference is significant. At a dose of 300 mg daily, 80% of patients experienced a positive response, with many feeling better. Additionally, sovleplenib is generally well-tolerated, allowing most patients to handle it without major issues. These results suggest that HMPL-523 could be a good option for people whose lymphoma hasn't improved with other treatments. ^{1 2 5 6 7}

Who Is on the Research Team?

Vijay Jayaprakash, MD

Principal Investigator

Hutchmed

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38885672/

Efficacy and safety of sovleplenib (HMPL-523) in adult ... The primary endpoint was met; durable response rate was 48% (61/126) with sovleplenib compared with zero with placebo (difference 48% [95% CI 40-57]; p<0·0001).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022356524171467

Preclinical Pharmacology Characterization of Sovleplenib ... At 300 mg QD, sovleplenib produced an encouraging overall response rate (80%) and a durable response rate (40%) (Liu et al., 2023; Yang et al., 2021; Ali et al.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11215356/

Phase I study of the Syk inhibitor sovleplenib in relapsed or ... In conclusion, sovleplenib demonstrated acceptable tolerability in B-cell lymphomas patients; encouraging anti-tumor activities were observed, ...

4. hutch-med.com hutch-med.com/hmpl-523-2021-ash/

HUTCHMED Highlights HMPL-523 Clinical Data ... The ESLIM-01 Phase III trial is underway to evaluate the efficacy and safety of HMPL-523 in treating adult patients with primary ITP, an autoimmune disorder ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03779113

NCT03779113 | An Open-label, Dose Escalation Trial to ... 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02857998

A Study of Hutchison MediPharma Limited(HMPL)-523 in ... A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms

7. medchemexpress.com medchemexpress.com/sovleplenib.html?srsltid=AfmBOorGtQIlQAQGt-Dc9XCq3ixg0ZJfvwJlsUZm_RTy19QuI_gHawSY

Sovleplenib (HMPL-523) | Syk Inhibitor Sovleplenib (HMPL-523; 100 mg/kg; daily oral administration) shows potent anti-tumor activity in B cell lymphoma REC-1 (TGI: 59%) in Syk dependent xenograft ...