Clinical trial · Interventional
A Study of Hutchison MediPharma Limited(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
NCT02857998CI-TRIAL-00078829completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mature B-cell Neoplasms | Mature B-Cell Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMPL-523 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HMPL-523
- description
- Oral 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.
- interventionNames
- Drug: HMPL-523
Primary outcomes (1)
- measure
- Dose limited toxicities evaluated with NCI CTCAE v4.03
- timeFrame
- within 28 days after the first dose
- description
- Incidence of dose limited toxicities and associated dose of HMPL-523
Secondary outcomes (4)
- measure
- Maximum plasma concentration calculated with Blood samples
- timeFrame
- within 29 days after the first dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Signed Informed Consent Form
2. Age \>=18 years
3. 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
4. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
5. Expected survival of more than 24 weeks as determined by the investigator
6. 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
Exclusion Criteria:
1. Patients with primary central nervous system(CNS) lymphoma
2. Any of the following laboratory abnormalities:
* Absolute neutrophil count\<1.5×109/L
* Hemoglobin \<80g/L
* Platelet\<75 ×109 /L
3. Inadequate organ function, defined by the following:
* 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.
4. 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.
5. Serum amylase or lipase \> the ULN
6. Serum creatinine \> 1.5 the ULN or estimated creatinine clearance \< 50 mL/min
7. International normalized ratio (INR)\>1.5 the ULN or activated partial thromboplastin time (aPTT)\>1.5 the ULN
8. 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)
9. Pregnant (positive pregnancy test) or lactating women
10. New York Heart Association (NYHA) Class II or greater congestive heart failure
11. Congenital long QT syndrome or corrected QT interval (QTc) \> 480 msec
12. Currently use medication known to cause QT prolongation.
13. 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).
14. Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy within 3 weeks prior to initiation of study treatment
15. Herbal therapy ≤1 week prior to initiation of study treatment
16. Prior treatment with any spleen tyrosine kinase (SYK) inhibitors (Fostamatinib)
17. 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
18. Clinically significant active infection (pneumonia)
19. Major surgical procedure within 4 weeks prior to initiation of study treatment
20. History of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment
21. Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease
22. Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1, except for alopeciaReferences
Publications (1)
- DERIVEDSong 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. PMID 38235512