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NCT Number: NCT07409428

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

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.

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Key information

Conditions

Relapsed/Refractory Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse 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 3

Primary location

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, China

Loading trial locations.

About this study

The study phases include screening period, treatment period, safety observation period, PFS follow-up period, and OS follow-up period.

The target population of this study includes patients with DLBCL who are relapsed or refractory.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

HMPL-760

Drug

Patients will receive HMPL-760 once daily (QD) orally.

HMPL-760 Placebo

Drug

Patients will receive HMPL-760 placebo once daily (QD) orally.

R-GemOx

Drug

R-GemOx regimen in 21-day cycles for a total of 8 cycles. Rituximab 375 mg/m2 IV is given on Day 1 of each cycle, and gemcitabine 1000 mg/m2 IV followed by oxaliplatin 100 mg/m2 IV is given on Day 2 of each cycle.

Other names: Rituximab Injection, Gemcitabine Hydrochloride for Injection, Oxaliplatin Injection

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: Up to approximately two years

    Investigator-assessed progression-free survival (PFS) Efficacy is evaluated using the Lugano Efficacy Evaluation Criteria for Malignant Lymphoma (Cheson 2014). PFS is defined as the time from randomization to PD or death due to any cause, whichever occurs first.

  2. End of treatment (EOT)

    Time frame: Up to approximately two years

    Tumor assessment data will continue to be collected. Tumor assessment data collected after end of treatment (EOT) will be used. Tumor assessment data collected during the study and after EOT will be included in the PFS analysis (treatment policy strategy).

  3. Systemic antitumor therapy

    Time frame: Up to approximately two years

    Use of other systemic antitumor therapy before PD or death (in the absence of PD):Tumor assessment after use of other systemic antitumor therapy will not be included in the analysis. For patients using other anti-tumor therapy before PD or death (in absence of PD), PFS will be censored at the last evaluable tumor assessment before the use of other systematic anti-tumor therapy (hypothetical strategy).

  4. Overall survival (OS)

    Time frame: Up to approximately two years

    OS is defined as the time from randomization to death due to any cause.

  5. systematic anti-tumor therapy

    Time frame: Up to approximately two years

    OS data will continue to be collected after the other systematic anti-tumor therapy, and the OS data collected before and after other systematic anti-tumor therapy will be included in analysis (treatment policy strategy).

  6. Premature withdrawal from study treatment

    Time frame: Up to approximately two years

    OS data will continue to be collected after the patient's premature withdrawal from study treatment, and the OS data collected during the study treatment and after EOT will be included in analysis (treatment policy strategy).

Secondary outcomes

  1. Independent review committee (IRC)-assessed PFS

    Time frame: Up to approximately two years

    Efficacy is evaluated using the Lugano Efficacy Evaluation Criteria for Malignant Lymphoma (Cheson 2014).

  2. IRC- and investigator-assessed objective response rate (ORR)

    Time frame: Up to approximately two years

    Objective Response Rate (ORR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR)

  3. IRC- and investigator-assessed complete response rate (CRR)

    Time frame: Up to approximately two years

    Complete response (CR) rate is defined as the ratio of patients with who reached complete response (CR)

  4. IRC- and investigator-assessed duration of response (DoR)

    Time frame: Up to approximately two years

    For patients who reached complete response (CR) or partial response (PR), Duration of Response (DoR) is defined as the time from the first CR or PR until disease progression or death due to any cause, whichever occurs first

  5. IRC- and investigator-assessed clinical benefit rate (CBR)

    Time frame: Up to approximately two years

    Defined as the ratio of patients with complete response (CR), partial response (PR), or stable disease (SD)

  6. IRC- and investigator-assessed time to response (TTR)

    Time frame: Up to approximately two years

    Time To Response (TTR) is defined as the time from the start of treatment to the first objective response rate (ORR)

  7. Safety Endpoints

    Time frame: Up to approximately two years

    • Incidence and severity of treatment-emergent adverse events (TEAEs), incidence of treatment-emergent serious adverse events (TESAEs), incidence of TEAEs leading to permanent discontinuation, dose interruption, and dose reduction, and their correlation to study drug. The severity is determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE 6.0).
    • Changes in laboratory tests, vital signs, 12-lead ECG, etc.

  8. PK characteristics of HMPL-760 in patients with R/R DLBCL when administered in combination with R-GemOx

    Time frame: At the end of Cycle 4 (each cycle is 21 days)]

    including but not limited to steady-state plasma concentrations of HMPL-760 pre-dose [trough concentrations (Ctrough)] and post-dose (C1h and C2h); If possible, a population pharmacokinetic (PPK) model can be used to generate PK parameters. If necessary, it can also be combined with other studies for model analysis.

    If possible, a population pharmacokinetic (PPK) model can be used to generate PK parameters. If necessary, it can also be combined with other studies for model analysis.

Other outcomes

  1. Biomarker assessment

    Time frame: Up to approximately two years

    Detect tumor driver gene mutations in tissue and blood samples, such as MYD88 and CD79B, etc, and explore the relationship between their mutation status and drug efficacy.

  2. To explore the metabolite profile of HMPL-760 in combination with R-GemOx in tumor patients

    Time frame: Up to approximately two years

    Human metabolites of HMPL-760 when co-administered with R-GemOx

  3. Pharmacokinetic parameters of gemcitabine and oxaliplatin when combined with HMPL-760

    Time frame: Up to approximately two years

    maximum concentration in steady-state (Cmax,ss)

  4. Pharmacokinetic parameters of gemcitabine and oxaliplatin when combined with HMPL-760

    Time frame: Up to approximately two years

    time to maximum concentration in steady-state (Tmax,ss)

  5. Pharmacokinetic parameters of gemcitabine and oxaliplatin when combined with HMPL-760

    Time frame: Up to approximately two years

    Area Under the Curve at steady state refers to the area under the plasma concentration-time curve during a dosing interval at steady state conditions (AUC,ss)

  6. Pharmacokinetic parameters of gemcitabine and oxaliplatin when combined with HMPL-760

    Time frame: Up to approximately two years

    The rate at which the drug is eliminated from the body (CL/F) (if applicable )

  7. Pharmacokinetic parameters of gemcitabine and oxaliplatin when combined with HMPL-760

    Time frame: Up to approximately two years

    The distribution volume calculated based on the terminal elimination phase (Vz/F )(if applicable)

Study contacts

Contact information is provided by the study sponsor or research team.

Dongmei Chen, CPL

CONTACT

[email protected]

86-21-20671794

Sponsors and collaborators

Lead sponsor

Hutchmed

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 13, 2026
Registry last updated
Jul 20, 2026

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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