Clinical trial · Interventional
HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-760 in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
NCT05190068CI-TRIAL-00088366completedPhase 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 Multicenter, Open-label, Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-760 in Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
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 |
|---|---|---|---|
| B-Cell Non-Hodgkin's Lymphoma | B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMPL-760 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Relapsed/refractory B-NHL
- description
- The starting dose of HMPL-760 is initially set as 50 mg, and then the doses of 100 mg, 200 mg, 300 mg, and 400 mg are escalated successively (this dose gradient is assumed). HMPL-760 was administered continuously as a single agent orally every day in sequential 28-day cycles.
- interventionNames
- Drug: HMPL-760
Primary outcomes (2)
- measure
- DLTs
- timeFrame
- Up to 28 days after first dose of study drug.
- description
- Number of subjects with Dose Limiting Toxicities (DLTs) with relapsed/refractory B-cell non-Hodgkin's lymphoma relapsed/refractory B-cell non-Hodgkin's lymphoma
- measure
- Safety and Tolerability
- timeFrame
- Baseline up to the end of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed Informed Consent Form (ICF) 2. Age ≥18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. In the expansion stage, ECOG performance status 0-2 4. Relapsed/refractory patients with histologically confirmed lymphoma * CLL confirmed by cytology (flow cytometry) * LPL/WM diagnosed by relevant tests including serum, bone marrow, and pathological examinations. 5. Except for CLL and WM, at least one bidimensionally measurable lesion is required by CT scan, which means the largest diameter of lymph node lesions \>1.5 cm or extranodal lesions \>1.0 cm; For lesions that cannot be well displayed by CT due to anatomical location (such as limb or soft tissue lesions), MRI measurement can be used. 6. Expected survival longer than 24 weeks Exclusion Criteria: Patients who met any of the following criteria are excluded from the study: 1. Lymphoma patients with central nervous system (CNS) or leptomeningeal invasion 2. Inadequate organ function of liver and kidney 3. Carcinoma in situ of the breast History of liver disease, including cirrhosis, alcoholism, or currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) 4. Any anti-tumor therapy including chemotherapy and radiotherapy within 3 weeks prior to the first dose of study drug 5. Within 7 days or approximately 5 half-lives (whichever is longer) prior to the first dose of the investigational drug, received any corticosteroids or approved small molecule targeted anti-cancer therapies. 6. Any monoclonal antibody used for anti-tumor therapy within 4 weeks or 2 half-lives prior to the first dose of study drug, whichever is longer 7. Prior use of any anti-tumor vaccine 8. Prior administration of radioimmunotherapy within 3 months prior to the first dose of study drug 9. Any uncontrolled active infection 10. History of drug-induced interstitial pneumonia
References
Publications (0)
Data not yet available
No reference posted for this study.