B-Cell Non-Hodgkin's LymphomaPhase 1NCT05190068
HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
A Phase 1 study testing HMPL-760 in people with B-Cell Non-Hodgkin's Lymphoma, run by Hutchmed at 22 sites in China.
Trial summary
A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-760 in Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Non-Hodgkin's Lymphoma
- What is being tested?
- HMPL-760
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 22 sitesChina
- Study dates
- 4 Jan 2022to 27 Jan 2025
- Phase
- Phase 1
- 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
- Signed Informed Consent Form (ICF)
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. In the expansion stage, ECOG performance status 0-2
- Relapsed/refractory patients with histologically confirmed lymphoma
- CLL confirmed by cytology (flow cytometry)
- LPL/WM diagnosed by relevant tests including serum, bone marrow, and pathological examinations.
- Except for CLL and WM, at least one bidimensionally measurable lesion is required by CT scan, which means the largest diameter of lymph node lesions >1.5 cm or extranodal lesions >1.0 cm; For lesions that cannot be well displayed by CT due to anatomical location (such as limb or soft tissue lesions), MRI measurement can be used.
- Expected survival longer than 24 weeks
Who cannot join
- Patients who met any of the following criteria are excluded from the study:
- Lymphoma patients with central nervous system (CNS) or leptomeningeal invasion
- Inadequate organ function of liver and kidney
- Carcinoma in situ of the breast History of liver disease, including cirrhosis, alcoholism, or currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Any anti-tumor therapy including chemotherapy and radiotherapy within 3 weeks prior to the first dose of study drug
- Within 7 days or approximately 5 half-lives (whichever is longer) prior to the first dose of the investigational drug, received any corticosteroids or approved small molecule targeted anti-cancer therapies.
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- Any monoclonal antibody used for anti-tumor therapy within 4 weeks or 2 half-lives prior to the first dose of study drug, whichever is longer
- Prior use of any anti-tumor vaccine
- Prior administration of radioimmunotherapy within 3 months prior to the first dose of study drug
- Any uncontrolled active infection
- History of drug-induced interstitial pneumonia
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality
Jilin Cancer Hospital
Changchun, Jilin
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi
Affiliated Hospital of Chengde Medical University
Chengde, Hebei
West China Hospital of Sichuan University
Chengdu, Sichuan
Chenzhou First People's Hospital
Chenzhou, Hunan
Chongqing university cancer hospital
Chongqing
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
Hangzhou, Zhejiang
Harbin Medical University Cancer Hospital
Harbin, Longjiang Hei
Qilu Hospital of Shandong University
Jinan, Shandong
Jiangxi Cancer Hospital
Nanchang, Jiangxi
Guangxi Medical University cancer Hospital & Guangxi Cancer Institute
Nanning, Guangxi
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
The First Hospital of China Medical University
Shenyang, Liaoning
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Shanxi Bethune Hospital
Taiyuan, Shanxi
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
The First Affiliated Hospital of Xiamen University
Xiameng, Fujian
Henan Cancer Hospital
Zhengzhou, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-760 in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-760 in Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Read the detailed description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-760 administered orally in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). Patients with relapsed/refractory B-NHL, including chronic lymphocytic leukemia/small cell lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular cell lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and lymphoplasmacytic/macroglobulinemia (LPL/WM).
- Conditions
- B-Cell Non-Hodgkin's Lymphoma
- Being tested
- HMPL-760
- Keywords
- B-Cell Non-Hodgkin's Lymphoma, Bruton's tyrosine kinase inhibitor
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-760Drug
HMPL-760 was administered continuously as a single agent orally every day in sequential 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| Relapsed/refractory B-NHL | Experimental | The starting dose of HMPL-760 is initially set as 50 mg, and then the doses of 100 mg, 200 mg, 300 mg, and 400 mg are escalated successively (this dose gradient is assumed).
HMPL-760 was administered continuously as a single agent orally every day in sequential 28-day cycles. Receives: Drug: HMPL-760 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs
Number of subjects with Dose Limiting Toxicities (DLTs) with relapsed/refractory B-cell non-Hodgkin's lymphoma relapsed/refractory B-cell non-Hodgkin's lymphoma
Measured: Up to 28 days after first dose of study drug.
Safety and Tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Baseline up to the end of study
Secondary outcomes (7)
Objective response rate (ORR)
Defined as the proportion of patients with CR/Partial response (PR)/CR with incomplete hematologic recovery (CRi)/ partial response with lymphocytosis (PR-L)
Measured: Baseline up to 6 months after the last patient was enrolled
Complete response rate (CR rate)
Defined as the proportion of patients with CR/CRi
Measured: Baseline up to 6 months after the last patient was enrolled
Progression-free survival (PFS)
Defined as the time from the first dose of HMPL-760 to occurrence of Progressive disease (PD) or death, whichever comes first
Measured: Baseline up to 6 months after the last patient was enrolled
Time to Response (TTR)
Defined as the time from the first dose of HMPL-760 to the first objective response
Measured: Baseline up to 6 months after the last patient was enrolled
Clinical Benefit Rate (CBR)
Defined as the proportion of patients with CR/CRi, PR/PR-L and Stable disease (SD)
Measured: Baseline up to 6 months after the last patient was enrolled
Duration of Response (DoR)
Defined as the time from the initial objective response to disease recurrence, progression or death
Measured: Baseline up to 6 months after the last patient was enrolled
Overall Survival (OS)
Defined as the time from the first dose to death due to any cause
Measured: Baseline up to 6 months after the last patient was enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start4 Jan 2022
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Non-Hodgkin's 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weili Zhao, Ph.D, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190068
- Sponsor's protocol ID
- 2021-760-00CH1
- Status last verified
- Apr 2025
- First submitted
- 10 Dec 2021
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-760 in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT05190068
- Acronym / sponsor ID
- 2021-760-00CH1
- Conditions
- B-Cell Non-Hodgkin's Lymphoma
- Keywords
- B-Cell Non-Hodgkin's Lymphoma, Bruton's tyrosine kinase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 13 Jan 2022 (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 Multicenter, Open-label, Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-760 in Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Detailed description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-760 administered orally in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). Patients with relapsed/refractory B-NHL, including chronic lymphocytic leukemia/small cell lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular cell lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and lymphoplasmacytic/macroglobulinemia (LPL/WM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsed/refractory B-NHL | Experimental | Drug: HMPL-760The starting dose of HMPL-760 is initially set as 50 mg, and then the doses of 100 mg, 200 mg, 300 mg, and 400 mg are escalated successively (this dose gradient is assumed). HMPL-760 was administered continuously as a single agent orally every day in sequential 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed Informed Consent Form (ICF)
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. In the expansion stage, ECOG performance status 0-2
- Relapsed/refractory patients with histologically confirmed lymphoma
- Except for CLL and WM, at least one bidimensionally measurable lesion is required by CT scan, which means the largest diameter of lymph node lesions >1.5 cm or extranodal lesions >1.0 cm; For lesions that cannot be well displayed by CT due to anatomical location (such as limb or soft tissue lesions), MRI measurement can be used.
Key exclusion criteria (11 listed)
- Lymphoma patients with central nervous system (CNS) or leptomeningeal invasion
- Inadequate organ function of liver and kidney
- Carcinoma in situ of the breast History of liver disease, including cirrhosis, alcoholism, or currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Any anti-tumor therapy including chemotherapy and radiotherapy within 3 weeks prior to the first dose of study drug
- Within 7 days or approximately 5 half-lives (whichever is longer) prior to the first dose of the investigational drug, received any corticosteroids or approved small molecule targeted anti-cancer therapies.
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 |
|---|---|---|
| HMPL-760HMPL-760 was administered continuously as a single agent orally every day in sequential 28-day cycles. | Drug | Relapsed/refractory B-NHL |
Primary outcome
DLTs
Time frame: Up to 28 days after first dose of study drug.
Number of subjects with Dose Limiting Toxicities (DLTs) with relapsed/refractory B-cell non-Hodgkin's lymphoma relapsed/refractory B-cell non-Hodgkin's lymphoma
Safety and Tolerability
Time frame: Baseline up to the end of study
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
7 secondary outcomes
Objective response rate (ORR)
Time frame: Baseline up to 6 months after the last patient was enrolled
Complete response rate (CR rate)
Time frame: Baseline up to 6 months after the last patient was enrolled
Progression-free survival (PFS)
Time frame: Baseline up to 6 months after the last patient was enrolled
Time to Response (TTR)
Time frame: Baseline up to 6 months after the last patient was enrolled
Clinical Benefit Rate (CBR)
Time frame: Baseline up to 6 months after the last patient was enrolled
Duration of Response (DoR)
Time frame: Baseline up to 6 months after the last patient was enrolled
Overall Survival (OS)
Time frame: Baseline up to 6 months after the last patient was enrolled
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 9 Apr 2025.
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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.
Weili Zhao, Ph.D principal investigator
Shanghai Jiao Tong University School of Medicine
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMPL-760 in people with B-Cell Non-Hodgkin's Lymphoma, run by Hutchmed at 22 sites 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 8 inclusion and 11 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 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
DLTs (time frame: Up to 28 days after first dose of study drug.). The study lists 2 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 9 Apr 2025.