New pill for tough lymphomas shows early promise, but trial stopped short

NCT ID NCT03779113

Disease control Sponsor: Hutchmed Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested an oral drug called HMPL-523 in 69 people with lymphoma that had returned or stopped responding to other treatments. The main goals were to check safety and find the right dose. The study was terminated early, so we have limited information on how well it works, but researchers did collect data on side effects and how the drug moves through the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: HMPL-523 (an oral drug that targets a protein called Syk, involved in cancer cell growth)
What this could lead to: If successful, HMPL-523 could offer a new treatment option for people with lymphoma who have run out of standard therapies.
What could go wrong: This was a very early (phase 1) trial that was terminated, so we don't know if the drug works well. It may cause side effects like low blood counts or other toxicities.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

69 people

The number who actually took part.

Started

Sep 2019

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients must meet the following criteria to be eligible for study entry: 1. Signed informed consent form (ICF). 2. Age ≥18 years. 3. ECOG performance status of 0 or 1. 4. Histologically confirmed lymphoma, including Hodgkin's lymphoma and non-Hodgkin's lymphoma. In the dose expansion stage, the tumor types may be restricted to any or all of the following tumor types. There may be approximately 10 patients in each cohort depending on response signals suggesting efficacy, except for 2 identified cohorts with approximately 20 patients per cohort: relapsed or refractory CLL/SLL, CLL/SLL post-BTK exposure (n=20), MCL, FL (Grade 1-3a) (n=20), MZL, WM/LPL, PTCL,CBCL, and/or HL 5. Patients with relapsed or refractory lymphoma who have exhausted all approved therapy options. 6. In the dose expansion stage, patients must have measurable disease for an objective response assessment, except for patients with CLL and WM/LPL 7. Availability of tumor sample for patients in dose expansion cohorts: This may be an archival tissue sample obtained after most recent therapy or a fresh biopsy; if tumor sample is not available, the Sponsor may waive the requirement after discussion 8. Expected survival of more than 24 weeks as determined by the investigator. 9. Male patients must agree to use a condom and female patients of childbearing potential must agree to use highly effective contraceptive measures for 30 days after the last dose of study drug. These include as combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal, and transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable), intrauterine contraceptive device, intrauterine hormone release system, bilateral tubal occlusion, or a vasectomized partner, provided that male partner is the sole sexual partner of the female patient. Postmenopausal females (women who have not had menses for at least 1 year without an alternative medical cause) are exempt from this criterion. Exclusion Criteria 1. Patients with primary central nervous system (CNS) lymphoma. 2. Any of the following laboratory abnormalities: Absolute neutrophil count\<1.0×10\^9/L, Hemoglobin \<80 g/L, Platelets \<50×10\^9/L 3. Inadequate organ function, defined by the following: Total bilirubin \>1.5 times the upper limit of normal (× ULN), aspartate aminotransferase and/or alanine aminotransferase \>2.5 × ULN, Estimated Creatinine Clearance (CrCl) per Cockcroft-Gault \[Dose Escalation portion of trial (Stage 1) CrCl \< 40 mL/min, Dose Expansion portion of trial (Stage 2) CrCl \< 30 mL/min\], Serum amylase or lipase \>ULN, International normalized ratio \>1.5 × ULN, or activated partial thromboplastin time \>1.5 × ULN 4. Patients with clinically detectable second primary malignant tumors at enrollment or other malignant tumors within the last 2 years (with the exception of radically treated basal cell or squamous cell carcinoma of the skin, in situ cervix, or in situ breast cancer). 5. Any anticancer therapy, including chemotherapy, hormonal therapy, biologic therapy, vaccine, or radiotherapy within 3 weeks prior to the initiation of study treatment. 6. Herbal therapy within 1 week prior to the initiation of study treatment. 7. Prior use of any anti-cancer vaccine 8. Prior treatment with any spleen tyrosine kinase (SYK) inhibitors (eg, fostamatinib) 9. Prior administration of radioimmunotherapy within 3 months before initiation of study treatment. 10. Use of strong cytochrome P450 isoform 3A inhibitors and inducers and drugs metabolized by cytochrome P450 isoform 3A, cytochrome P450 isoform 2B6, and cytochrome P450 isoform 1A2, and are identified as narrow therapeutic drugs within 7 days or 3 half-lives, whichever is longer, prior to initiation of study treatment 11. Adverse events from prior anticancer therapy that have not resolved to Grade ≤1, except for alopecia. 12. Prior autologous stem cell transplant within 6 months prior to the initiation of study treatment. 13. Prior allogeneic stem cell transplant within 6 months prior to the initiation of study treatment or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to the initiation of study treatment. 14. Clinically significant active infection (eg, pneumonia). 15. Major surgical procedure within 4 weeks prior to the initiation of study treatment. 16. Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus. 17. Pregnant (positive serum beta human chorionic gonadotropin test) or lactating women. 18. New York Heart Association Class II or greater congestive heart failure. 19. Congenital long QT syndrome or correct QT interval using Fridericia's formula (QTcF) \>480 msec 20. Current use of medication known to cause QT prolongation or Torsades de Pointes 21. History of myocardial infarction or unstable angina within 6 months prior to the initiation of study treatment. 22. History of stroke or transient ischemic attack within 6 months prior to the initiation of study treatment. 23. Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease. 24. Treatment in a clinical study within 30 days prior to the initiation of study treatment. 25. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, or renders the patient at high risk from treatment complications.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia Hodgkins lymphoma lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-Hodgkin lymphoma

Contacts and locations

Locations

Aarhus University Hospital

Aarhus, Denmark
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

Bergamo, Bergamo, 24127, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

Monza, Italy
CHU Clermont Ferrand - Hôpital d'Estaing

Clermont-Ferrand, France
CHU Poitiers - Hôpital la Milétrie

Poitiers, France
Clinical Research Alliance

New Hyde Park, New York, 11042, United States
Fundacion Jimenez Diaz

Madrid, Spain
Groupe Hospitalier Pitie-Salpetriere

Paris, France
Helsingin yliopistollinen keskussairaala

Helsinki, 00029, Finland
Hospital Universitari Vall d'Hebron

Barcelona, Spain
Hospital Universitario Infanta Leonor

Madrid, Spain
Hospital Universitario Quironsalud Madrid

Madrid, Spain
Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain
Hospital Universitario Virgen Macarena

Seville, Spain
Hospital Universitario Virgen del Rocio

Seville, Spain
Hôpital Henri Mondor

Créteil, France
ICO Badalona - Hospital Universitari Germans Trias i Pujol

Barcelona, Spain
Innovative Clinical Research Institute

Downey, California, 90241, United States
Institut Català d'Oncologia

Barcelona, Spain
KO-MED Centra Kliniczne

Biała Podlaska, Poland
Leo Jenkins Cancer Center/ECU School of Medicine

Greenville, North Carolina, 27834, United States
MD Anderson Cancer Centre

Madrid, Spain
Nasz Lekarz Przychodnie Medyczne

Torun, Poland
Ospedale San Raffaele

Milan, Milano, 20132, Italy
Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States
Renovatio Clinical

The Woodlands, Texas, 77380, United States
Summit Medical Group

Florham Park, New Jersey, 07932, United States
Tampereen yliopistollinen sairaala

Tampere, 33520, Finland
The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego

Wroclaw, 50566, Poland
Uniwersyteckie Centrum Kliniczne

Gdansk, Poland
Ventura County Hematology-Oncology Specialists

Oxnard, California, 93030, United States

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