Clinical trial · Interventional
A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma
A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma
NCT05713110CI-TRIAL-00084930completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A phase II clinical study of tazemetostat combined with HMPL-689 in patients with R/R lymphoma. The study includes 2 phases: dose escalation phase (phase IIa) and expansion phase (phase IIb).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMPL-689 | Drug | — | UNRESOLVED |
| tazemetostat | Drug | Tazemetostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- tazemetostat combined with HMP689 open-label treatment arm
- description
- Dose Escalation Phase (Phase IIa): patients with relapsed or refractory lymphoma who have failed standard treatment and have no standard treatment options Dose Expansion Phase (Phase IIb): Cohort 1 (DLBCL, FL 3b): Histologically confirmed DLBCL, FL 3b (including primary mediastinal B-cell lymphoma) with relapsed/refractory disease ； Cohort 2 (FL) patients with histologically confirmed R/R FL (Grade 1, 2, 3a)； Cohort 3 (MCL): Patients with R/R MCL who had prior therapies ； Cohort 4 (PTCL): Patients with histologically confirmed R/R PTCL who have failed or cannot tolerate standard therapy
- interventionNames
- Drug: tazemetostat
- Drug: HMPL-689
Primary outcomes (5)
- measure
- Dose Escalation Phase (Phase IIa):To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or RP2D of Tazemetostat in combination with HMPL-689 in patients with R/R lymphoma
- timeFrame
- from Cycle 1 Day 1 up to Cycle 1 Day 28 (each cycle is 28 days)
- description
- Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Criteria: Inclusion Criteria: 1. Willing and able to give informed consent, as documented by signed ICF 2. Age ≥ 18 years 3. Patients with histologically confirmed R/R lymphoma: • Phase IIa （dose escalation study）: patients with relapsed or refractory lymphoma who have failed standard treatment and have no standard treatment options • Phase IIb（ expansion Study ）: Cohort 1 (DLBCL, FL 3b) Histologically confirmed DLBCL, FL 3b (including primary mediastinal B-cell lymphoma) with relapsed/refractory disease Cohort 2 (FL) patients with histologically confirmed R/R FL (Grade 1, 2, 3a) Cohort 3 (MCL): Patients with R/R MCL who had prior therapies Cohort 4 (PTCL): Patients with histologically confirmed R/R PTCL who have failed or cannot tolerate standard therapy 4. Patients must have at least one measurable lesion 5. Life expectancy ≥ 12 weeks 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Adequate bone marrow function, renal function and hepatic function: 8. Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) is inactive 9. Female patients of childbearing potential must agree to use a double contraception method and male patients with partners of childbearing potential must also use an effective double contraception method during the study period and for 3 months after the final dose Exclusion Criteria: 1. Patients who have previously used EZH2 inhibitors and PI3K inhibitors, or previously could not tolerate EZH2 inhibitors or PI3K inhibitors 2. Patients with brain metastases or leptomeningeal invasion 3. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE 5.0 criteria) and any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS / AML/MPN) 4. Has abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and multiple primary neoplasms (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing
References
Publications (0)
Data not yet available
No reference posted for this study.