A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Relapsed/Refractory Diffuse Large B-Cell Lymphoma

In brief

This is a Phase III randomized, double-blind, positive 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 R/R DLBCL.

Key facts

Study ID

NCT07409428

Run by

Hutchmed

People needed

240

Starts

2026-03-20

Expected to finish

2028-12-30

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sign the ICF and be able to follow the requirements of study protocol;
• Age ≥18 years;
• ECOG performance status score between 0 and 2;
• Histopathologically confirmed diagnosis of DLBCL;
• The investigator judges that the patient's current condition requires further treatment;
• Patients should have at least one bi-dimensionally measurable lesion;
• Expected survival is more than 12 weeks;

You may not qualify if…

• Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;
• Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;
• Organ insufficiency;
• 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);
• History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;
• Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);
• The toxic reactions of previous anti-tumor therapy have not recovered to the level of ≤ grade 1 (except for alopecia and decreased appetite and other conditions that have been clearly required in the inclusion and exclusion criteria);
• Clinically significant active infection;

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
• Baoding NO.1 Central Hospital — Baoding, China (enrolling)
• Beijing GoBroad Hospital — Beijing, China (enrolling)
• BEIJING TONGREN HOSPITAL, Capital Medical University — Beijing, China (enrolling)
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, China (enrolling)
• The First Hospital of Jilin University — Changchun, China (enrolling)
• Hunan Cancer Hospital — Changsha, China (enrolling)
• People's Hospital of Hunan Province — Changsha, China (enrolling)
• The Second Xiangya Hospital of Central South University — Changsha, China (enrolling)
• Sichuan Provincial People's Hospital — Chengdu, China (enrolling)
• West China Hospital of Sichuan University — Chengdu, China (enrolling)
• Chongqing University Cancer Hospital — Chongqing, China (enrolling)
• The Affiliated Hospital of Qingdao University — Qingdao, China (enrolling)
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (enrolling)
• Tongji Hospital of Tongji University — Shanghai, China (enrolling)
• Shanxi Provincial Cancer Hospital — Taiyuan, China (enrolling)
• North China University of Science and Technology Affiliated Hospital — Tangshan, China (enrolling)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, China (enrolling)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (enrolling)
• Tianjin People's Hospital — Tianjin, China (enrolling)
• Hubei Cancer Hospital — Wuhan, China (enrolling)
• Wuhan Union Hospital of China — Wuhan, China (enrolling)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (enrolling)

Full record on ClinicalTrials.gov

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