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Trial Title:
A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma
NCT ID:
NCT05713110
Condition:
Relapsed/Refractory Lymphoma
Conditions: Official terms:
Lymphoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
tazemetostat
Description:
Dose Escalation Phase (Phase IIa):
Tazemetostat (800 mg BID orally) in a therapeutic cycle of 28 days;
Dose Expansion Phase (Phase IIb):
Tazemetostat (800 mg BID orally) in a therapeutic cycle of 28 days
Arm group label:
tazemetostat combined with HMP689 open-label treatment arm
Intervention type:
Drug
Intervention name:
HMPL-689
Description:
Dose Escalation Phase (Phase IIa):
HMPL-689:20 mg and 30 mg, QD orally in a therapeutic cycle of 28 days.
Dose Expansion Phase (Phase IIb):
HMPL-689 (RP2D) in a therapeutic cycle of 28 days
Arm group label:
tazemetostat combined with HMP689 open-label treatment arm
Summary:
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).
Detailed description:
Dose Escalation Phase (Phase IIa ):Including 10-20 patients for dose escalation, the
enrollment will continue until about 10 patients in the dose group with response, as to
determine Recommended Phase II dose (RP2D).
Dose Expansion Phase (Phase IIb):Multiple expansion cohorts will be set up according to
different tumor types, and about 15-20 patients will be enrolled in each cohort to
further observe the anti-tumor effect of Tazemetostat combined with HMPL-689 in different
pathological types of R/R lymphoma.
This study is expected to enroll 85-140 patients total in Phase IIa and phase IIb.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ciming Cai
Phone:
13621999905
Email:
cmc_girl@163.com
Investigator:
Last name:
Weili Zhao
Email:
Principal Investigator
Start date:
February 13, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Hutchmed
Agency class:
Industry
Source:
Hutchmed
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05713110
