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

December 13, 2022 updated by: Hutchison Medipharma Limited

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
          • Tao Yang, Ph.D
        • Contact:
          • Yi Gong, Ph.D
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Weili Zhao, Ph.D
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Keshu Zhou, Ph.D
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • Guohui Cui, Ph.D
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Recruiting
        • First Affiliated Hospital of Soochow University
        • Contact:
          • Caixia Li, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relapsed/refractory B-NHL

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLTs
Time Frame: Up to 28 days after first dose of study drug.
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
Time Frame: Baseline up to the end of study
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Baseline up to the end of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Baseline up to the last patient has completed 12 months after treatment
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
Complete response rate (CR rate)
Time Frame: Baseline up to the last patient has completed 12 months after treatment
Defined as the proportion of patients with CR/CRi
Baseline up to the last patient has completed 12 months after treatment
Progression-free survival (PFS)
Time Frame: Baseline up to the last patient has completed 12 months after treatment
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
Time to Response (TTR)
Time Frame: Baseline up to the last patient has completed 12 months after treatment
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
Clinical Benefit Rate (CBR)
Time Frame: Baseline up to the last patient has completed 12 months after treatment
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
Duration of Response (DoR)
Time Frame: Baseline up to the last patient has completed 12 months after treatment
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
Overall Survival (OS)
Time Frame: Baseline up to the last patient has completed 60 months after treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hutchison Medipharma Limited

Investigators

  • Principal Investigator: Weili Zhao, Ph.D, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

December 10, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-760-00CH1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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