HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

HUTCHMED

Status and phase: Completed; Phase 1

Conditions: B-Cell Non-Hodgkin's Lymphoma

Treatments: Drug: HMPL-760

Study type: Interventional

Funder types: Industry

Identifiers

NCT05190068

2021-760-00CH1

Details and patient eligibility

About

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

Full description

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-760 administered orally in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). Patients with relapsed/refractory B-NHL, including chronic lymphocytic leukemia/small cell lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular cell lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and lymphoplasmacytic/macroglobulinemia (LPL/WM).

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

Relapsed/refractory B-NHL

Experimental group

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.

Treatment:

Drug: HMPL-760