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

B-Cell Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05190068
• Other study ID #: 2021-760-00CH1
• Status: Recruiting
• Phase: Phase 1
• Start date: January 4, 2022
• Est. completion date: April 2026

Study information

• Verified date: December 2022
• Source: Hutchmed
• Contact: Jian Chen, Ph.D
• Phone: 021-20671942
• Email: Jianc2[@]hutch-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2026
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 or cytologically confirmed CLL (flow cytometry)

5. At least one bidimensionally measurable lesion by CT with the exception of CLL, i.e., nodal lesions > 1.5 cm in maximal diameter or extranodal lesions > 1.0 cm;

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. Receipt of small molecule targeted therapy with approved anti-tumor therapy within 7 days or approximately 5 half-lives (whichever is longer) prior to the first dose of study drug

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

Related Conditions & MeSH terms

• B-Cell Non-Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• HMPL-760
HMPL-760 was administered continuously as a single agent orally every day in sequential 28-day cycles.

Locations

Country	Name	City	State
China	Chongqing university cancer hospital	Chongqing
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai
China	First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Hutchison Medipharma Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLTs	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	Up to 28 days after first dose of study drug.
Primary	Safety and Tolerability	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Baseline up to the end of study
Secondary	Objective response rate (ORR)	Defined as the proportion of patients with CR/Partial response (PR)/CR with incomplete hematologic recovery (CRi)/ partial response with lymphocytosis (PR-L)	Baseline up to the last patient has completed 12 months after treatment
Secondary	Complete response rate (CR rate)	Defined as the proportion of patients with CR/CRi	Baseline up to the last patient has completed 12 months after treatment
Secondary	Progression-free survival (PFS)	Defined as the time from the first dose of HMPL-760 to occurrence of Progressive disease (PD) or death, whichever comes first	Baseline up to the last patient has completed 12 months after treatment
Secondary	Time to Response (TTR)	Defined as the time from the first dose of HMPL-760 to the first objective response	Baseline up to the last patient has completed 12 months after treatment
Secondary	Clinical Benefit Rate (CBR)	Defined as the proportion of patients with CR/CRi, PR/PR-L and Stable disease (SD)	Baseline up to the last patient has completed 12 months after treatment
Secondary	Duration of Response (DoR)	Defined as the time from the initial objective response to disease recurrence, progression or death	Baseline up to the last patient has completed 12 months after treatment
Secondary	Overall Survival (OS)	Defined as the time from the first dose to death due to any cause	Baseline up to the last patient has completed 60 months after treatment