HMPL-523 for Lymphoma

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Hutchison Medipharma Limited

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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.

Treatment Details

Interventions

• HMPL-523 (Small Molecule Inhibitor)

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+