Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL

Last updated: November 19, 2024
Sponsor: Hutchmed
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma, B-cell

Lymphoma

Treatment

HMPL-760 placebo planned dose 2

HMPL-760 planned dose 1

HMPL-760 planned dose 2

Clinical Study ID

NCT06601504
2024-760-00CH1
  • Ages > 18
  • All Genders

Study Summary

The goal of this study is to evaluate the efficacy of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sign the Informed consent form(ICF) and be able to follow the requirements of studyprotocol;

  2. Age ≥18 years;

  3. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2;

  4. Histopathologically confirmed diagnosis of DLBCL;

  5. The investigator judges that the patient's current condition requires furthertreatment;

  6. Patients should have at least one bi-dimensionally measurable lesion;

  7. Expected survival is more than 12 weeks;

Exclusion

Exclusion Criteria:

  1. Patients with known primary or secondary central nervous system lymphoma (CNSL) orthe presence of clinical symptoms suggestive of CNSL;

  2. Women who are pregnant (positive pregnancy test during the screening period) orbreastfeeding;

  3. Organ insufficiency;

  4. Currently known history of liver disease, including cirrhosis, alcoholic liver,known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV):

  5. History of significant organ bleeding, including gastrointestinal bleeding,hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of studydrug;

  6. Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia;or the patient is receiving vitamin K antagonist (warfarin);

  7. Toxicities from prior anticancer therapy not resolved to Grade ≤ 1 (except foralopecia and decreased appetite);

  8. Clinically significant active infection;

Study Design

Total Participants: 60
Treatment Group(s): 5
Primary Treatment: HMPL-760 placebo planned dose 2
Phase: 2
Study Start date:
November 05, 2024
Estimated Completion Date:
November 12, 2026

Study Description

A Phase II Randomized, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 in Combination with R-GemOx versus Placebo in Combination with R-GemOx in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL). The study phases include screening period, treatment period, safety observation period, PFS follow-up period, and OS follow-up period.

Connect with a study center

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Third Affiliated Hospital,SUNYAT-SEN UNIVERSITY

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The Second People's Hospital of Shenzhen

    Shenzhen, Guangdong
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi
    China

    Site Not Available

  • Affiliated Hospital od Chengde Medical University

    Chengde, Hebei
    China

    Active - Recruiting

  • Wuhan Union Hospital of China

    Wuhan, Hebei
    China

    Site Not Available

  • Harbin First Hospital

    Harbin, Heilongjiang
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • Shandong Cancer Hospital & Institute

    Jinan, Shandong
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    Tianjin, Tianjin
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang
    China

    Site Not Available

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