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Mature B-cell NeoplasmsPhase 1NCT02857998

A Study of Hutchison MediPharma Limited(HMPL)-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms

A Phase 1 study testing HMPL-523 in people with Mature B-cell Neoplasms, run by Hutchison Medipharma Limited at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mature B-cell Neoplasms
What is being tested?
HMPL-523
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
2 sitesChina
Study dates
27 Dec 2016to 30 Sep 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form
  • Age >=18 years
  • Histologically relapsed or refractory mature B-cell Neoplasms, have failed at least one prior therapy or patients who are unable to tolerate standard therapy or no curative therapy or therapy of higher priority exists
  • Eastern Cooperative Oncology Group（ECOG） performance status of 0 or 1
  • Expected survival of more than 24 weeks as determined by the investigator
  • In expansion stage, Subjects should have at least one dual diameter measurable lesion expect for subject with CLL or subject with LPL/WM with abonormal immunoglobulin

Who cannot join

  • Patients with primary central nervous system(CNS) lymphoma
  • Any of the following laboratory abnormalities:
  • Absolute neutrophil count<1.5×109/L
  • Hemoglobin <80g/L
  • Platelet<75 ×109 /L
  • Inadequate organ function, defined by the following:
Show all 27Show fewer
  • Total bilirubin >1.5the ULN with the following exception:
  • Patients with known Gilbert disease who have serum bilirubin level ≤3 the upper limit of normal(ULN) and normal Aspartate aminotransferase(AST)/Alanine aminotransferase(ALT) may be enrolled.
  • AST and/or ALT > 2.5 the ULN with the following exception:Patients with documented disease infiltration of the liver may have AST and/or ALT levels ≤ 5 the ULN.
  • Serum amylase or lipase > the ULN
  • Serum creatinine > 1.5 the ULN or estimated creatinine clearance < 50 mL/min
  • International normalized ratio (INR)>1.5 the ULN or activated partial thromboplastin time (aPTT)>1.5 the ULN
  • Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
  • Pregnant (positive pregnancy test) or lactating women
  • New York Heart Association (NYHA) Class II or greater congestive heart failure
  • Congenital long QT syndrome or corrected QT interval (QTc) > 480 msec
  • Currently use medication known to cause QT prolongation.
  • Subjects with presence of 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).
  • Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy within 3 weeks prior to initiation of study treatment
  • Herbal therapy ≤1 week prior to initiation of study treatment
  • Prior treatment with any spleen tyrosine kinase (SYK) inhibitors (Fostamatinib)
  • Prior allogeneic stem cell transplant within 6 months prior to initiation of study treatment or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to initiation of study treatment
  • Clinically significant active infection (pneumonia)
  • Major surgical procedure within 4 weeks prior to initiation of study treatment
  • History of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment
  • Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1, except for alopecia

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • BeijingCancer Hospital

    Beijing, Beijing Municipality

  • Fudan University Shanghai Cancer Hospital

    Shanghai, 200032

Other trials in China

About this study

Official title: 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

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

Read the detailed description

There are two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2).

Dose-escalation stage (stage 1):

The conventional 3+3 design (3 patients per dose cohort, with the potential to add additional 3 patients to the same cohort to further evaluate toxicity) will be applied for dose escalation and maximum tolerated dosage determination. Approximately 27 to 42 dose limited toxicities evaluable patients will be enrolled. The actual number of patients depends on the dose limited toxicities situation as well as the maximum tolerated dosage reached at this stage.

Dosing will begin at 200mg once daily. A cycle of study treatment will be defined as 28 days of continuous dosing.

Dose-expansion stage (stage 2):

This phase is to further evaluate the safety, the pharmacokinetics and anti-tumor activity of HMPL-523 at recommended phase 2 dosage in approximately 190 patients with relapsed or refractory Hematologic Malignancies.

In this stage, approximately 190 patients with Mature B-cell Neoplasms will be enrolled with recommended phase 2 dosage 600milligram(mg) one a day(QD) as starting dosing. The tumor types of the expansion stage are restricted to Chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL), Mantle cell lymphoma (MCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL), Marginal zone lymphoma (MZL)and Waldenstrom's macroglobulinemia (WM)/Lymphoplasmacytic lymphoma(LPL) Subjects will receive HMPL-523 with every 28-day treatment cycle until disease progression, death, or intolerable toxicity, whichever comes first.

Being tested
HMPL-523

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HMPL-523Drug

    Also called HMPL-523 Acetate

    Oral administration, once daily

Study groups in NCT02857998
Study groupRoleWhat they receive
HMPL-523ExperimentalOral administration, at dose of 200, 400, 600 and 800 mg once daily;at dose of 200,300, 400mg twice daily at Dose-escalation stage; At Dose-expansion stage, if patients dosing at 600mgQD.
Receives: Drug: HMPL-523

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limited toxicities evaluated with NCI CTCAE v4.03

    Incidence of dose limited toxicities and associated dose of HMPL-523

    Measured: within 28 days after the first dose

Secondary outcomes (4)

  1. Maximum plasma concentration calculated with Blood samples

    Blood samples will be taken to measure the levels of study drug

    Measured: within 29 days after the first dose

  2. Time to reach maximum concentration calculated with Blood samples

    Blood samples will be taken to measure the levels of study drug

    Measured: within 29 days after the first dose

  3. Objective response rate

    the proportion of subjects who have a Complete Response or Partial Response

    Measured: within 30 days after the last dose

  4. Adverse events evaluated by NCI CTCAE v4.03

    Incidence of adverse events and associated dose of HMPL-523

    Measured: from the first dose to within 30 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2016 (estimated)
  2. Study start27 Dec 2016
  3. Primary completion30 Jun 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02857998
Sponsor's protocol ID
2015-523-00CH1
Status last verified
Jul 2024
First submitted
3 Aug 2016
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Song Y, Cao J, Zhang Q, Li C, Qiu L, Qi J, Zhang H, Li W, Liu L, Jing H, Zhou K, Zhang W, Zhang L, Li D, Zou L, Yang H, Qian W, Zhou H, Hu J, Yin H, Fu S, Fan S, Xu Q, Wang J, Jia X, Dai G, Su W, Zhu J. Phase I study of the Syk inhibitor sovleplenib in relapsed or refractory mature B-cell tumors. Haematologica. 2024 Jul 1;109(7):2165-2176. doi: 10.3324/haematol.2022.282401.

    PubMed 38235512

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HMPL-523 in people with Mature B-cell Neoplasms, run by Hutchison Medipharma Limited at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limited toxicities evaluated with NCI CTCAE v4.03 (time frame: within 28 days after the first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02857998, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.

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