HMPL-760 with R‑GemOx versus placebo with R‑GemOx for relapsed or refractory diffuse large B‑cell lymphoma

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 Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

This trial will see if adding HMPL‑760 to R‑GemOx helps adults with relapsed or refractory diffuse large B‑cell lymphoma respond better or live longer than R‑GemOx plus placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hutchmed (Industry-sponsored)
• Locations: 41 sites (Shanghai, Shanghai Municipality and 40 other locations)
• Trial ID: NCT07409428 on ClinicalTrials.gov

What this trial studies

This is a randomized, double‑blind, placebo‑controlled Phase III trial comparing HMPL‑760 plus R‑GemOx to placebo plus R‑GemOx in patients with relapsed or refractory DLBCL. Participants undergo screening, receive assigned study treatment during the treatment period, and are followed for safety, progression‑free survival, and overall survival. The study also collects pharmacokinetic data to characterize HMPL‑760 exposure. Sites for enrollment include several tertiary hospitals in China.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed relapsed or refractory DLBCL, ECOG 0–2, at least one measurable lesion, and an expected survival over 12 weeks who need further treatment are the intended participants.

Not a fit: Patients with known or suspected central nervous system lymphoma, pregnant or breastfeeding women, those with significant organ insufficiency or active HIV/HBV/HCV infection, or a history of major bleeding are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, adding HMPL‑760 to R‑GemOx could improve tumor response rates and prolong progression‑free survival compared with R‑GemOx alone.

How similar studies have performed: Combining targeted agents with chemo has shown benefit in some B‑cell lymphomas but results in relapsed/refractory DLBCL have been variable, and this Phase III builds on earlier‑phase work with HMPL‑760.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;
2. Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;
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 study drug;
6. Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);
7. 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);
8. Clinically significant active infection;

Where this trial is running

Shanghai, Shanghai Municipality and 40 other locations

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Baoding NO.1 Central Hospital — Baoding, China (Not_yet_recruiting)
• Beijing GoBroad Hospital — Beijing, China (Not_yet_recruiting)
• BEIJING TONGREN HOSPITAL, Capital Medical University — Beijing, China (Not_yet_recruiting)
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, China (Not_yet_recruiting)
• The First Hospital of Jilin University — Changchun, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, China (Not_yet_recruiting)
• People's Hospital of Hunan Province — Changsha, China (Not_yet_recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, China (Not_yet_recruiting)
• Sichuan Provincial People's Hospital — Chengdu, China (Not_yet_recruiting)
• West China Hospital of Sichuan University — Chengdu, China (Not_yet_recruiting)
• Chongqing University Cancer Hospital — Chongqing, China (Not_yet_recruiting)
• Quanzhou First Hospital.Fujian — Fujian, China (Not_yet_recruiting)
• Fujian Medical University Union Hospital — Fuzhou, China (Not_yet_recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, China (Not_yet_recruiting)
• ZhuJiang Hospital of Southern Medical University（The Second Clinical Medical College） — Guangzhou, China (Not_yet_recruiting)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, China (Not_yet_recruiting)
• The First Affiliated Hospital, Zhejiang University — Hangzhou, China (Not_yet_recruiting)
• Zhejiang Cancer Hospital — Hangzhou, China (Not_yet_recruiting)
• Harbin Medical University Cancer Hospital — Harbin, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Anhui Medical University — Hefei, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University — Jinan, China (Not_yet_recruiting)
• Shandong Cancer Hospital & Institute — Jinan, China (Not_yet_recruiting)
• Jiangxi Cancer Hospital — Nanchang, China (Not_yet_recruiting)
• Jiangsu Cancer Hospital — Nanjing, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, China (Not_yet_recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, China (Not_yet_recruiting)
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (Not_yet_recruiting)
• Tongji Hospital of Tongji University — Shanghai, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, China (Not_yet_recruiting)
• Shanxi Provincial Cancer Hospitial — Taiyuan, China (Not_yet_recruiting)
• North China University of Science and Technology Affiliated Hospital — Tangshan, China (Not_yet_recruiting)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, China (Recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (Not_yet_recruiting)
• Tianjin People's Hospital — Tianjin, China (Not_yet_recruiting)
• Cancer Hospital Affiliated to Xinjiang Medical University — Ürümqi, China (Not_yet_recruiting)
• Hubei Cancer Hospital — Wuhan, China (Not_yet_recruiting)
• Wuhan Union Hospital of China — Wuhan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Weili Zhao — Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
• Study coordinator: Dongmei Chen, CPL

Conditions Relapsed/Refractory Diffuse Large B-Cell Lymphoma; HMPL-760; R-GemOx; R/R DLBCL