Non Hodgkin LymphomaPhase 1/2NCT04024696
A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients
A Phase 1/2 study testing Abexinostat in people with Non Hodgkin Lymphoma, run by Xynomic Pharmaceuticals, Inc. at 4 sites in China.
Trial summary
This is an open-label, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- Abexinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesChina
- Study dates
- 8 Jan 2020to 30 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis o f non Hodgkin's lymphoma
- Patients with non-Hodgkin's lymphoma who have either failed standard of care or are intolerant/unapplicable to therapy;
- Subject who has no growth factor supportive therapy, transfusion of blood or blood products within 14 days before the enrollment test
- The patient is capable and willing to accept the follow up according to the protocol and signed or provided the ICF signed by the legal representative
- Contraceptive measures , definition of women of childbearing age and contraceptive requirements
Who cannot join
- Subjects who have received anti tumor therapy and have not recovered from previous toxicity reactions ( toxicity reactions unrecovered to grade 1 as per NCI CTCAE 5.0
- Subjects who received major surgery (excluding diagnostic biopsy)within 28 days prior to the first dose.
- Subjects who received autologous stem cell transplantation within 3 months or allogeneic stem cell transplantation within 6 months prior to the first dose with active graft versus host response at screening
- Subjects with use of prohibited medication within 7 days or less than 5 half lives prior to the first dose (whichever is shorter), see prohibited medication list
- Participated in other interventional clinical trial within 1 month or 5 half life periods prior to the first dose (whichever is longer), except for non intervention clinical trials
- Evidence suggests that there may be human immunodeficiency virus (HIV) infection , or hepatitis C (HCV) hepatitis virus infection PCR RNA positive);
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- Uncontrolled systemic infection or infection requiring intravenous injection of antibiotics
- Lymphoma with central nervous system (CNS) involvement
- Subjects with concurrent other malignant tumors in addition to the studied tumor within 2 years prior to the first dosing , except for the controlled skin basal cell carcinoma , cervical carcinoma in situ, ductal carcinoma in situ , and papillary thyroid carcinoma
- Subject is known to be allergic to the components of abexinostat
- Pregnant and lactating subjects
- Upon the investigator's judgment , the subject has any disease or medical condition that is unstable or may affect safety or study compliance , such as uncontrolled hypertension,uncontrolled diabetes, active bleeding , etc.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
Zhejiang Cancer Hospital
Hangzhou, 310022
Tianjin Medical University General Hospital
Tianjin, 300052
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221006
About this study
Official title: An Open-Label, Non-Randomized Clinical Study to Evaluate Pharmacokinetic (PK) Profiles, Safety, and Tolerability of Abexinostat Monotherapy in Patients With Non-Hodgkin's Lymphoma Who Have Failed Standard of Care
This is an open-label, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of the oral monotherapy of abexinostat.
Read the detailed description
This is an open-label, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of the oral monotherapy of abexinostat.
Three (3) dose groups are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC). A total of 12-16 subjects in the RP2D dose group will be required to accept PK blood sampling for the analysis of PK profiles and parameters. The patients will continue treatment until the occurrence of a DLT event, disease progression, intolerant toxicity, withdrawal of ICF, treatment discontinuation determined by the investigator, lost to follow-up, death, or termination of the study, (whichever occurs first).
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- Abexinostat
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbexinostatDrug
Abexinostat Tosylate Tablets
| Study group | Role | What they receive |
|---|---|---|
| Dosing Cohorts | Experimental | Three (3) dose cohorts are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC). Receives: Drug: Abexinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure AUC at Different Dose Level
Measure Area under the plasma concentration versus time curve (AUC) levels at different dose level
Measured: Up to 6 month
Measure Cmax at Different Dose Level
Measure Peak Plasma Concentration (Cmax at different dose level
Measured: Up to 6 month
Determine the maximum tolerated dose
Determine the maximum tolerated dose based on observed dose-limiting toxicity at different dose levels
Measured: Up to 6 month
Secondary outcomes (2)
Measure Objective Response Rate
Measure objective response rate in % at the RP2D in patients with non-Hodgkin's lymphoma who have failed standard of care
Measured: Up to 12 Month
Measure Duration of Response
Measure duration of response in months at the RP2D in patients with non-Hodgkin's lymphoma who have failed standard of care
Measured: Up to 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start8 Jan 2020
- Primary completion30 Dec 2024
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Cohort 1: 40 mg BID Cohort 2: 60 mg BID Cohort 3: 80 mg BID
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, M.D.; Prof, Principal investigator, Cancer Hospital Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024696
- Sponsor's protocol ID
- XYN-609
- Status last verified
- Apr 2025
- First submitted
- 9 Jul 2019
- Last updated
- 10 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gui L, Xie Z, Qin Y, Liu P, Yang J, Chen X, Li Z, Tao R, Shi Y. Safety, pharmacokinetics, and efficacy of abexinostat, an novel histone deacetylase inhibitor, in Chinese patients with relapsed/refractory B cell non-Hodgkin lymphoma: a Phase 1 study. BMC Cancer. 2025 May 30;25(1):967. doi: 10.1186/s12885-025-14370-y.
PubMed 40442628
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized Clinical Study to Evaluate Pharmacokinetic (PK) Profiles, Safety, and Tolerability of Abexinostat Monotherapy in Patients With Non-Hodgkin's Lymphoma Who Have Failed Standard of Care
- ClinicalTrials.gov ID
- NCT04024696
- Acronym / sponsor ID
- XYN-609
- Conditions
- Non Hodgkin Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 18 Jul 2019 (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.
This is an open-label, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of the oral monotherapy of abexinostat.
Detailed description
This is an open-label, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of the oral monotherapy of abexinostat.
Three (3) dose groups are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC). A total of 12-16 subjects in the RP2D dose group will be required to accept PK blood sampling for the analysis of PK profiles and parameters. The patients will continue treatment until the occurrence of a DLT event, disease progression, intolerant toxicity, withdrawal of ICF, treatment discontinuation determined by the investigator, lost to follow-up, death, or termination of the study, (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort 1: 40 mg BID Cohort 2: 60 mg BID Cohort 3: 80 mg BID
| Arm | Type | Receives |
|---|---|---|
| Dosing Cohorts | Experimental | Drug: AbexinostatThree (3) dose cohorts are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed diagnosis o f non Hodgkin's lymphoma
- Patients with non-Hodgkin's lymphoma who have either failed standard of care or are intolerant/unapplicable to therapy;
- Subject who has no growth factor supportive therapy, transfusion of blood or blood products within 14 days before the enrollment test
- The patient is capable and willing to accept the follow up according to the protocol and signed or provided the ICF signed by the legal representative
- Contraceptive measures , definition of women of childbearing age and contraceptive requirements
Key exclusion criteria (12 listed)
- Subjects who have received anti tumor therapy and have not recovered from previous toxicity reactions ( toxicity reactions unrecovered to grade 1 as per NCI CTCAE 5.0
- Subjects who received major surgery (excluding diagnostic biopsy)within 28 days prior to the first dose.
- Subjects who received autologous stem cell transplantation within 3 months or allogeneic stem cell transplantation within 6 months prior to the first dose with active graft versus host response at screening
- Subjects with use of prohibited medication within 7 days or less than 5 half lives prior to the first dose (whichever is shorter), see prohibited medication list
- Participated in other interventional clinical trial within 1 month or 5 half life periods prior to the first dose (whichever is longer), except for non intervention clinical trials
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 |
|---|---|---|
| AbexinostatAbexinostat Tosylate Tablets | Drug | Dosing Cohorts |
Primary outcome
Measure AUC at Different Dose Level
Time frame: Up to 6 month
Measure Area under the plasma concentration versus time curve (AUC) levels at different dose level
Measure Cmax at Different Dose Level
Time frame: Up to 6 month
Measure Peak Plasma Concentration (Cmax at different dose level
Determine the maximum tolerated dose
Time frame: Up to 6 month
Determine the maximum tolerated dose based on observed dose-limiting toxicity at different dose levels
2 secondary outcomes
Measure Objective Response Rate
Time frame: Up to 12 Month
Measure Duration of Response
Time frame: Up to 12 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 40442628Gui L, Xie Z, Qin Y, Liu P, Yang J, Chen X, Li Z, Tao R, Shi Y. Safety, pharmacokinetics, and efficacy of abexinostat, an novel histone deacetylase inhibitor, in Chinese patients with relapsed/refractory B cell non-Hodgkin lymphoma: a Phase 1 study. BMC Cancer. 2025 May 30;25(1):967. doi: 10.1186/s12885-025-14370-y.
- 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.
Yuankai Shi, M.D.; Prof principal investigator
Cancer Hospital Chinese Academy of Medical Science
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Abexinostat in people with Non Hodgkin Lymphoma, run by Xynomic Pharmaceuticals, Inc. at 4 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 5 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 10 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 4 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
Measure AUC at Different Dose Level (time frame: Up to 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04024696, which also lists 1 linked publication.
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 10 Apr 2025.