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

NCT06601504 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2024-760-00CH1
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 16

Brief 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).

Conditions

Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Keywords

R-GemOx; R/R DLBCL; HMPL-760

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (PFS): Efficacy is evaluated using the Lugano Efficacy Evaluation Criteria for Malignant Lymphoma (Cheson 2014).

  Up to approximately 2 years

Secondary Outcomes (13)

• Objective Response Rate (ORR)

  Up to approximately 2 years

• Complete response (CR) rate

  Up to approximately 2 years

• Duration of response (DoR)

  Up to approximately 2 years

• Clinical benefit rate (CBR)

  Up to approximately 2 years

• Time to response (TTR)

  Up to approximately 2 years

Other Outcomes (2)

• Biomarker assessment

  Up to approximately 2 years

• Metabolite analysis of HMPL-760 in combination with R-GemOx

  At the end of Cycle 7 (each cycle is 21 days)

Study Arms (4)

Group A: HMPL-760 planned dose 1 once daily (QD) in combination with R-GemOx regimen

EXPERIMENTAL

Group A: Patients will receive HMPL-760 planned dose 1 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m\^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m\^2 ivgtt is given, followed by oxaliplatin 100 mg/m\^2 ivgtt on day 2 of each cycle.

Drug: HMPL-760 planned dose 1; Drug: R-GemOx

Group B: HMPL-760 placebo planned dose 1 once daily (QD) in combination with R-GemOx regimen

PLACEBO COMPARATOR

Patients will receive HMPL-760 placebo planned dose 1 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m\^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m\^2 ivgtt is given, followed by oxaliplatin 100 mg/m\^2 ivgtt on day 2 of each cycle.

Drug: R-GemOx; Drug: HMPL-760 placebo planned dose 1

Group C: HMPL-760 planned dose 2 once daily (QD) in combination with R-GemOx regimen

EXPERIMENTAL

Patients will receive HMPL-760 planned dose 2 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m\^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m\^2 ivgtt is given, followed by oxaliplatin 100 mg/m\^2 ivgtt on day 2 of each cycle.

Drug: R-GemOx; Drug: HMPL-760 planned dose 2

Group D: HMPL-760 placebo planned dose 2 once daily (QD) in combination with R-GemOx regimen

PLACEBO COMPARATOR

Patients will receive HMPL-760 placebo planned dose 2 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m\^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m\^2 ivgtt is given, followed by oxaliplatin 100 mg/m\^2 ivgtt on day 2 of each cycle.

Drug: R-GemOx; Drug: HMPL-760 placebo planned dose 2

Interventions

HMPL-760 planned dose 1 DRUG

HMPL-760 planned dose 1 daily (QD) orally

Group A: HMPL-760 planned dose 1 once daily (QD) in combination with R-GemOx regimen

R-GemOx DRUG

R-GemOx regimen includes Rituximab Injection, Gemcitabine Hydrochloride for Injection, Gemcitabine Hydrochloride for Injection. R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m\^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m\^2 ivgtt is given, followed by oxaliplatin 100 mg/m\^2 ivgtt on day 2 of each cycle.

Also known as: Rituximab Injection, Gemcitabine Hydrochloride for Injection, Gemcitabine Hydrochloride for Injection

Group A: HMPL-760 planned dose 1 once daily (QD) in combination with R-GemOx regimen; Group B: HMPL-760 placebo planned dose 1 once daily (QD) in combination with R-GemOx regimen; Group C: HMPL-760 planned dose 2 once daily (QD) in combination with R-GemOx regimen; Group D: HMPL-760 placebo planned dose 2 once daily (QD) in combination with R-GemOx regimen

HMPL-760 placebo planned dose 1 DRUG

HMPL-760 placebo planned dose 1 daily (QD) orally

Group B: HMPL-760 placebo planned dose 1 once daily (QD) in combination with R-GemOx regimen

HMPL-760 planned dose 2 DRUG

HMPL-760 planned dose 2 daily (QD) orally

Group C: HMPL-760 planned dose 2 once daily (QD) in combination with R-GemOx regimen

HMPL-760 placebo planned dose 2 DRUG

HMPL-760 placebo planned dose 2 daily (QD) orally

Group D: HMPL-760 placebo planned dose 2 once daily (QD) in combination with R-GemOx regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the Informed consent form(ICF) and be able to follow the requirements of study protocol;
• Age ≥18 years;
• Eastern Cooperative Oncology Group (ECOG) performance status 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);
• Toxicities from prior anticancer therapy not resolved to Grade ≤ 1 (except for alopecia and decreased appetite);
• Clinically significant active infection;

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (16)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Location

Wuhan Union Hospital of China

Wuhan, Hebei, China

Location

Harbin First Hospital

Harbin, Heilongjiang, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

Shandong Cancer Hospital & Institute

Jinan, Shandong, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

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

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Gemcitabine; Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Weili Zhao

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): May 12, 2026
• Study Completion (Estimated): November 12, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)