Relapsed/Refractory LymphomaPhase 2NCT05713110
A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma
A Phase 2 study testing tazemetostat and HMPL-689 in people with Relapsed/Refractory Lymphoma, run by Hutchmed at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Lymphoma
- What is being tested?
- tazemetostat and HMPL-689
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2023to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients who have previously used EZH2 inhibitors and PI3K inhibitors, or previously could not tolerate EZH2 inhibitors or PI3K inhibitors
- Patients with brain metastases or leptomeningeal invasion
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
About this study
Official title: 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
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).
Read the 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.
- Conditions
- Relapsed/Refractory Lymphoma
- Being tested
- tazemetostat, HMPL-689
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tazemetostatDrug
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
HMPL-689Drug
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
| Study group | Role | What they receive |
|---|---|---|
| tazemetostat combined with HMP689 open-label treatment arm | Experimental | 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 Receives: Drug: tazemetostat; Drug: HMPL-689 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period
Measured: from Cycle 1 Day 1 up to Cycle 1 Day 28 (each cycle is 28 days)
Dose Expansion Phase (Phase IIb):To evaluate the ORR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
Percentage of patients with Complete Response(CR) or Partial Response(PR) as the best response evaluated in accordance with Lugano2014
Measured: from Cycle 1 Day 1 to PFS (each cycle is 28 days)
Dose Expansion Phase (Phase IIb):To evaluate the DCR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
the proportion of patients with CR or PR or stable disease (SD) as the best response with Lugano2014
Measured: from Cycle 1 Day 1 to PFS (each cycle is 28 days)
Dose Expansion Phase (Phase IIb):To evaluate the DOR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
as the time from the first appearance of CR or PR to PD or death for any reason (whichever comes first), in the patients with objective response with Lugano2014)
Measured: from Cycle 1 Day 1 to PFS (each cycle is 28 days)
Dose Expansion Phase (Phase IIb):To evaluate the PFS of Tazemetostat in combination with HMPL-689 in patients with lymphoma
the proportion of patients with CR or PR or stable disease (SD) as the best response with Lugano2014
Measured: from Cycle 1 Day 1 to PFS (each cycle is 28 days)
Secondary outcomes (18)
Dose Escalation Phase (Phase IIa):Objective Response Rate (ORR)
Percentage of patients with Complete Response (CR) or Partial Response (PR) as the best response evaluated in accordance with Lugano 2014
Measured: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Complete Response Rate (CR rate)
Percentage of patients with Complete Response (CR) as the best response evaluated in accordance with Lugano 2014
Measured: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Disease control rate (DCR)
the proportion of patients with CR or PR or stable disease (SD) as the best response
Measured: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Duration of response (DoR)
as the time from the first appearance of CR or PR to PD or death for any reason (whichever comes first), in the patients with objective response
Measured: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Time to response (TTR)
the time from the first dose of Tazemetostat in combination with HMPL-689 to the first objective response
Measured: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Progression-free survival (PFS)
time from the first dose of study treatment to PD or death for any reason, whichever comes first
Measured: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Overall survival (OS)
time from the first dose of study treatment to death for any reason
time from the first dose of study treatment to death for any reason
Measured: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Expansion Phase (Phase IIb)-Evaluation of Tazemetostat safety and tolerability in Combination with HMPL-689 in Patients with R/R Lymphoma
Incidence, severity, and causality to study drug of treatment-emergent adverse events (TEAEs) as determined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE 5.0)
Measured: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Geomean maximum concentration (Cmax) of tazemetostat and its metabolite EPZ-6930 in blood
Cmax is defined as the maximum observed concentration that a drug achieves in a test area of the body after the drug has been administered. Plasma concentration-time profiles of tazemetostat and EPZ-6930 will be plotted using non-compartmental analysis and will be analyzed to determine Cmax. Cmax will be summarized as the geomean and geomean CV% for all participants.
Measured: Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D2, C1D16, C2D1, C3D1 and C4D1: PoFA
Median time to reach maximum concentration (Tmax) of tazemetostat and its metabolite EPZ-6930 in blood
Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered. Plasma concentration-time profiles of tazemetostat and EPZ-6930 will be plotted using non-compartmental analysis and will be analyzed to determine Tmax. Tmax will be summarized as the median (min, max) for all participants.
Measured: Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D2, C1D16, C2D1, C3D1 and C4D1: PoFA
Geomean area under the drug concentration-time curve (AUC) of tazemetostat and its metabolite EPZ-6930 after administration of tazemetostat
AUC represents the total drug exposure over a defined period of time. AUC will be calculated using the linear trapezoidal rule. Plasma concentrations of tazemetostat and EPZ-6930 will be analyzed using a non-compartmental analysis approach to determine individual participant estimates of AUC. AUC will be summarized as the geomean and geomean CV% for all participants
Measured: Cycle (C) 1, Day (D) 1: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose.
Geomean minimum observed concentration at steady-state (Cmin) of tazemetostat and its metabolite EPZ-6930 in blood
Cmin is defined as the minimum observed concentration at steady-state during one dosing interval. Cmin will be summarized as the geomean and geomean CV% for all participants.
Measured: C1D15, C1D16, C2D1, C3D1 and C4D1: PoFA
Geomean maximum concentration (Cmax) of HMPL-689 in blood
Cmax is defined as the maximum observed concentration that a drug achieves in a test area of the body after the drug has been administered. Plasma concentration-time profiles of HMPL-689 will be plotted using non-compartmental analysis and will be analyzed to determine Cmax. Cmax will be summarized as the geomean and geomean CV% for all participants.
Measured: Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D2, PoFA) hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D16, PoFA) hours postdose. C2D1, C3D1 and C4D1: PoFA
Median time to reach maximum concentration (Tmax) of HMPL-689 in blood
Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered. Plasma concentration-time profiles of HMPL-689 will be plotted using non-compartmental analysis and will be analyzed to determine Tmax. Tmax will be summarized as the median (min, max) for all participants
Measured: Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D2, PoFA) hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D16, PoFA) hours postdose. C2D1, C3D1 and C4D1: PoFA
Geomean area under the drug concentration-time curve (AUC) of HMPL-689 after administration of HMPL-689
AUC represents the total drug exposure over a defined period of time. AUC will be calculated using the linear trapezoidal rule. Plasma concentrations of HMPL-689 will be analyzed using a non-compartmental analysis approach to determine individual participant estimates of AUC. AUC will be summarized as the geomean and geomean CV% for all participants.
Measured: Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D2, PoFA) hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D16, PoFA) hours postdose
Geomean minimum observed concentration at steady-state (Cmin) of HMPL-689 in blood
Cmin is defined as the minimum observed concentration at steady-state during one dosing interval. Cmin will be summarized as the geomean and geomean CV% for all participants
Measured: C1D15, C1D16, C2D1, C3D1 and C4D1: PoFA
To investigate the preliminary efficacy and PK correlation
The efficacy of participants as assessed by Lugano2014 from different dose groups, to assess the correlation of efficacy and PK of tazemetostat and HMPL-689
Measured: through study completion, an average of 2 years
To investigate the preliminary tolerability and PK relationship
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 from different dose groups, to assess the correlation of safety and PK of tazemetostat and HMPL-689
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start13 Feb 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory LymphomaStudies of the same condition, open and under way.
- More trials run by HutchmedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin Yang, Study director, Hutchison Medipharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713110
- Sponsor's protocol ID
- 2021-TAZ-00CH2
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05713110
- Acronym / sponsor ID
- 2021-TAZ-00CH2
- Conditions
- Relapsed/Refractory Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tazemetostat combined with HMP689 open-label treatment arm | Experimental | Drug: tazemetostat, Drug: HMPL-689Dose 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients who have previously used EZH2 inhibitors and PI3K inhibitors, or previously could not tolerate EZH2 inhibitors or PI3K inhibitors
- Patients with brain metastases or leptomeningeal invasion
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tazemetostatDose 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 | Drug | tazemetostat combined with HMP689 open-label treatment arm |
| HMPL-689Dose 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 | Drug | tazemetostat combined with HMP689 open-label treatment arm |
Primary outcome
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
Time frame: from Cycle 1 Day 1 up to Cycle 1 Day 28 (each cycle is 28 days)
Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period
Dose Expansion Phase (Phase IIb):To evaluate the ORR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
Time frame: from Cycle 1 Day 1 to PFS (each cycle is 28 days)
Percentage of patients with Complete Response(CR) or Partial Response(PR) as the best response evaluated in accordance with Lugano2014
Dose Expansion Phase (Phase IIb):To evaluate the DCR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
Time frame: from Cycle 1 Day 1 to PFS (each cycle is 28 days)
the proportion of patients with CR or PR or stable disease (SD) as the best response with Lugano2014
Dose Expansion Phase (Phase IIb):To evaluate the DOR of Tazemetostat in combination with HMPL-689 in patients with lymphoma
Time frame: from Cycle 1 Day 1 to PFS (each cycle is 28 days)
as the time from the first appearance of CR or PR to PD or death for any reason (whichever comes first), in the patients with objective response with Lugano2014)
Dose Expansion Phase (Phase IIb):To evaluate the PFS of Tazemetostat in combination with HMPL-689 in patients with lymphoma
Time frame: from Cycle 1 Day 1 to PFS (each cycle is 28 days)
the proportion of patients with CR or PR or stable disease (SD) as the best response with Lugano2014
18 secondary outcomes
Dose Escalation Phase (Phase IIa):Objective Response Rate (ORR)
Time frame: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Complete Response Rate (CR rate)
Time frame: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Disease control rate (DCR)
Time frame: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Duration of response (DoR)
Time frame: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Time to response (TTR)
Time frame: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Progression-free survival (PFS)
Time frame: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Escalation Phase (Phase IIa)-Overall survival (OS)
Time frame: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Dose Expansion Phase (Phase IIb)-Evaluation of Tazemetostat safety and tolerability in Combination with HMPL-689 in Patients with R/R Lymphoma
Time frame: From baseline to final assessment at end of safety follow-up visit(through study completion, an average of 2 years)
Geomean maximum concentration (Cmax) of tazemetostat and its metabolite EPZ-6930 in blood
Time frame: Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D2, C1D16, C2D1, C3D1 and C4D1: PoFA
Median time to reach maximum concentration (Tmax) of tazemetostat and its metabolite EPZ-6930 in blood
Time frame: Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D2, C1D16, C2D1, C3D1 and C4D1: PoFA
Geomean area under the drug concentration-time curve (AUC) of tazemetostat and its metabolite EPZ-6930 after administration of tazemetostat
Time frame: Cycle (C) 1, Day (D) 1: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose.
Geomean minimum observed concentration at steady-state (Cmin) of tazemetostat and its metabolite EPZ-6930 in blood
Time frame: C1D15, C1D16, C2D1, C3D1 and C4D1: PoFA
Geomean maximum concentration (Cmax) of HMPL-689 in blood
Time frame: Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D2, PoFA) hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D16, PoFA) hours postdose. C2D1, C3D1 and C4D1: PoFA
Median time to reach maximum concentration (Tmax) of HMPL-689 in blood
Time frame: Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D2, PoFA) hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D16, PoFA) hours postdose. C2D1, C3D1 and C4D1: PoFA
Geomean area under the drug concentration-time curve (AUC) of HMPL-689 after administration of HMPL-689
Time frame: Cycle (C) 1, Day (D) 1: predose of first administration (PoFA); 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D2, PoFA) hours postdose. C1D15: PoFA; 0.5, 1, 2, 4, 6, 8, 12 and 24 (C1D16, PoFA) hours postdose
Geomean minimum observed concentration at steady-state (Cmin) of HMPL-689 in blood
Time frame: C1D15, C1D16, C2D1, C3D1 and C4D1: PoFA
To investigate the preliminary efficacy and PK correlation
Time frame: through study completion, an average of 2 years
To investigate the preliminary tolerability and PK relationship
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Yang study director
Hutchison Medipharma Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tazemetostat and HMPL-689 in people with Relapsed/Refractory Lymphoma, run by Hutchmed at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: from Cycle 1 Day 1 up to Cycle 1 Day 28 (each cycle is 28 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.