Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HMPL-689 · 3 trials · 4 indications
Defined as the proportion of patients with CR or PR
Incidence of dose limited toxicities and associated dose of HMPL-689
Overall response rate (ORR) is defined as the proportion of patients who have a CR or PR
| Arm | Type | Description |
|---|---|---|
| Relapsed/Refractory MZL and FL | EXPERIMENTAL | Relapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma |
| Six arm including in dose expansion stage by following: | EXPERIMENTAL | * Arm A: patients with MZL (subtype including nodal, extra-nodal and splenic) who received ≥ 1 previous line of systematic treatment and at least one line included CD20-directed regimen * Arm B: patients with CLL/SLL who received ≥ 1 previous line of systematic treatment and at least one of which included purine-based regimen or CD20-directed regimen * Arm C: patients with FL (grade 1, 2, and 3a) who received ≥ 2 previous line of systematic treatment and at least one line included CD20-directed regimen * Arm D: patients with MCL who received ≥ 2 previous line of systematic treatment and at least one line included CD20-directed regimen * Arm E: patients with DLBCL (including GCB and non-GCB, Richter' transformation) who received ≥ 2 previous line of systematic treatment and at least one line included CD20-directed regimen * Arm F: patients with PTCL who received ≥ 2 previous line of systematic treatment |
| HMPL-689 | EXPERIMENTAL | Subjects will receive a single dose of HMPL-689 or matching placebo on Day 1. The planned dose levels in ascending order are: 1, 2.5, 5, 10, 20, 25 and 30 mg (7 dose cohorts with 8 subjects in each cohort). Within each cohort, randomization ratio of 3:1 is followed to dose 6 subjects with HMPL-689 and 2 subjects with placebo. |
| HMPL-689 placebo | PLACEBO_COMPARATOR | Subjects will receive a single dose of HMPL-689 or matching placebo on Day 1. The planned dose levels in ascending order are: 1, 2.5, 5, 10, 20, 25 and 30 mg (7 dose cohorts with 8 subjects in each cohort). Within each cohort, randomization ratio of 3:1 is followed to dose 6 subjects with HMPL-689 and 2 subjects with placebo. |
| Name | Type | Description |
|---|---|---|
| HMPL-689 | DRUG | All patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles. |
| HMPL-689 placebo | DRUG | placebo of HMPL-689 |
Inclusion Criteria: 1. Age ≥18 years; 2. Patients with relapsed/refractory marginal zone lymphoma or follicular lymphoma 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-2; 4. At least one measurable lesion by computerised tomography (CT) / magnetic resonance imaging (MRI) (t...
HMPL-689 is an investigational small molecule being developed by HUTCHMED (China) Limited (HCM). It has been studied in healthy volunteers and in patients with lymphomas, including marginal zone lymphoma and follicular lymphoma. As of the available data, it is in clinical development and has not been approved.
HMPL-689 is being studied for use in lymphomas, specifically relapsed or refractory marginal zone lymphoma and follicular lymphoma. It has also been evaluated in healthy volunteers in early-phase trials. Its clinical development has focused on patients who have failed standard of care or for whom no standard of care exists.
HMPL-689 is developed by HUTCHMED (China) Limited, a biopharmaceutical company listed under the ticker HCM. The company has conducted clinical trials of HMPL-689 in Australia and China.
HMPL-689 has completed Phase 1 and Phase 2 clinical trials. The completed trials include a Phase 1 study in healthy volunteers, a Phase 1 study in patients with lymphomas, and a Phase 2 study in patients with marginal zone lymphoma and follicular lymphoma. It remains an investigational drug.
HMPL-689 has been studied in three completed clinical trials. NCT02631642 was a Phase 1 study in healthy volunteers in Australia. NCT03128164 was a Phase 1 study in patients with lymphomas in China. NCT04849351 was a Phase 2 study for relapsed or refractory marginal zone lymphoma and follicular lymphoma in China.
HMPL-689 is the drug name used in clinical trials. No alternative names have been reported for this investigational therapy.