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Completed

NCT Number: NCT05190068

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

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Key information

Conditions

B-cell Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Chao-Yang Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

HMPL-760

Drug

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Baseline up to 6 months after the last patient was enrolled

    Defined as the proportion of patients with CR/Partial response (PR)/CR with incomplete hematologic recovery (CRi)/ partial response with lymphocytosis (PR-L)

  2. Complete response rate (CR rate)

    Time frame: Baseline up to 6 months after the last patient was enrolled

    Defined as the proportion of patients with CR/CRi

  3. Progression-free survival (PFS)

    Time frame: Baseline up to 6 months after the last patient was enrolled

    Defined as the time from the first dose of HMPL-760 to occurrence of Progressive disease (PD) or death, whichever comes first

  4. Time to Response (TTR)

    Time frame: Baseline up to 6 months after the last patient was enrolled

    Defined as the time from the first dose of HMPL-760 to the first objective response

  5. Clinical Benefit Rate (CBR)

    Time frame: Baseline up to 6 months after the last patient was enrolled

    Defined as the proportion of patients with CR/CRi, PR/PR-L and Stable disease (SD)

  6. Duration of Response (DoR)

    Time frame: Baseline up to 6 months after the last patient was enrolled

    Defined as the time from the initial objective response to disease recurrence, progression or death

  7. Overall Survival (OS)

    Time frame: Baseline up to 6 months after the last patient was enrolled

    Defined as the time from the first dose to death due to any cause

Sponsors and collaborators

Lead sponsor

Hutchmed

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2022
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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