Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HMPL-760 planned dose 1, Rabeprazole
HMPL-760 · 4 trials · 3 indications
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.
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).
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).
OS is defined as the time from randomization to death due to any cause.
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).
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).
| Arm | Type | Description |
|---|---|---|
| The experimental group | EXPERIMENTAL | Patients will receive HMPL-760 once daily (QD) orally in combination with 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. |
| The control group | PLACEBO_COMPARATOR | Placebo QD at the same dose as HMPL-760 in the experimental group will be given in the control group, and the combination therapy is the same as in the experimental group. |
| Name | Type | Description |
|---|---|---|
| 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. |
| HMPL-760 planned dose 1 | DRUG | HMPL-760 planned dose 1 daily (QD) orally |
| HMPL-760 placebo planned dose 1 | DRUG | HMPL-760 placebo planned dose 1 daily (QD) orally |
| HMPL-760 planned dose 2 | DRUG | HMPL-760 planned dose 2 daily (QD) orally |
| HMPL-760 placebo planned dose 2 | DRUG | HMPL-760 placebo planned dose 2 daily (QD) orally |
| Itraconazole 200 mg | DRUG | Study participants will be administered 200 mg itraconazole by mouth twice daily after the pharmacokinetic blood draw on Day 3 and once daily on Days 4 to 10, inclusive. |
| Fluconazole 400 mg | DRUG | Study participants will be administered 400 mg fluconazole by mouth daily on Day 3 after the pharmacokinetic blood draw, and 200 mg fluconazole by mouth daily on Days 4 to 10, inclusive. |
| Rifampin 600 mg | DRUG | Study participants will be administered 600 mg rifampin by mouth daily starting on Day 3, after the pharmacokinetic blood draw, and on Days 4 to 11, inclusive. |
| Rabeprazole 40 mg | DRUG | Study participants will be administered 40 mg rabeprazole by mouth daily on Day 3, after the pharmacokinetic blood draw, and on Days 4 to 9, inclusive. |
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 tre...
HMPL-760 is an investigational small molecule being studied for B-cell non-Hodgkin's lymphoma, relapsed or refractory lymphoma, and relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is being developed as a treatment for patients whose lymphomas have returned or have not responded to prior therapy.
HMPL-760 targets BTK, Bruton's tyrosine kinase, a kinase enzyme involved in B-cell receptor signaling. By inhibiting BTK, HMPL-760 is designed to interfere with signaling pathways that support the growth and survival of malignant B cells in lymphomas such as diffuse large B-cell lymphoma.
HMPL-760 is being developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company is running clinical studies of the compound in lymphoma, including a Phase III trial in relapsed or refractory diffuse large B-cell lymphoma in China.
HMPL-760 is in clinical development, with Phase 1 studies completed and later-stage trials ongoing. A Phase III study of HMPL-760 plus R-GemOx versus placebo plus R-GemOx in relapsed or refractory diffuse large B-cell lymphoma is currently recruiting, and a Phase II study in the same setting is active but not recruiting.
HMPL-760 has been studied in several registered trials. These include NCT07409428, a recruiting Phase III trial in relapsed or refractory DLBCL, NCT06601504, an active Phase II trial in the same indication, and completed Phase 1 studies NCT05190068 in relapsed or refractory B-cell non-Hodgkin's lymphoma and NCT05602597, a drug interaction study.
No. HMPL-760 is a BTK-targeting small molecule developed by HUTCHMED, while rabeprazole is a proton pump inhibitor. Rabeprazole appears in HMPL-760 research only as a study component, for example in a drug interaction study evaluating HMPL-760 with a PPI, so the two are distinct agents.