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

NCT05190068 | Completed Phase 1

• 1 other identifier: 2021-760-00CH1
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 22

Brief 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

Conditions

B-Cell Non-Hodgkin's Lymphoma

Keywords

B-Cell Non-Hodgkin's Lymphoma; Bruton's tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (7)

• Objective response rate (ORR)

  Baseline up to 6 months after the last patient was enrolled

• Complete response rate (CR rate)

  Baseline up to 6 months after the last patient was enrolled

• Progression-free survival (PFS)

  Baseline up to 6 months after the last patient was enrolled

• Time to Response (TTR)

  Baseline up to 6 months after the last patient was enrolled

• Clinical Benefit Rate (CBR)

  Baseline up to 6 months after the last patient was enrolled

Study Arms (1)

Relapsed/refractory B-NHL

EXPERIMENTAL

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.

Drug: HMPL-760

Interventions

HMPL-760 DRUG

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

Relapsed/refractory B-NHL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form (ICF)
• Age ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. In the expansion stage, ECOG performance status 0-2
• 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.
• 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.
• Expected survival longer than 24 weeks

You may not qualify if:

• Patients who met any of the following criteria are excluded from the study:
• Lymphoma patients with central nervous system (CNS) or leptomeningeal invasion
• Inadequate organ function of liver and kidney
• 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)
• Any anti-tumor therapy including chemotherapy and radiotherapy within 3 weeks prior to the first dose of study drug
• 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.
• 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
• Prior use of any anti-tumor vaccine
• Prior administration of radioimmunotherapy within 3 months prior to the first dose of study drug
• Any uncontrolled active infection
• History of drug-induced interstitial pneumonia

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (22)

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Xiamen University

Xiameng, Fujian, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Guangxi Medical University cancer Hospital & Guangxi Cancer Institute

Nanning, Guangxi, China

Location

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Chenzhou First People's Hospital

Chenzhou, Hunan, China

Location

First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Location

Jilin Cancer Hospital

Changchun, Jilin, China

Location

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

Harbin Medical University Cancer Hospital

Harbin, Longjiang Hei, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Chongqing university cancer hospital

Chongqing, China

Location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Weili Zhao, Ph.D

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 13, 2022
• Study Start: January 4, 2022
• Primary Completion: January 27, 2025
• Study Completion: January 27, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

CN (22)