Non-Hodgkin LymphomaPhase 1NCT06484985
Study of AXT-1003 in Subjects With Advanced Malignant Tumors.
A Phase 1 study testing AXT-1003 in people with Non-Hodgkin Lymphoma and Advanced Solid Tumor, run by Axter Therapeutics (Beijing) Co., Ltd at 5 sites in China.
Trial summary
This is a Phase I study of AXT-1003 to assess the safety, tolerability, and pharmacokinetics in patients with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma, Advanced Solid Tumor
- What is being tested?
- AXT-1003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 5 sitesChina
- Study dates
- 4 Sep 2024to Sep 2027
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Ia dose escalation part only:
- R/R NHL: Locally histopathological diagnosis of relapsed/refractory non-Hodgkin lymphoma (R/R NHL), who have progressed or been intolerant after the available standard therapies, or have no access to the standard therapies.
- Advanced solid tumors: Locally histopathological diagnosis of locally advanced unresectable and metastatic solid tumors,The above subjects have progressed or been intolerant after the available standard therapies, or have no access to the standard therapies.
- For Ib dose expansion part only: Subjects with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL)
- Eastern Cooperative Oncology Group (ECOG) performance status scale 0 to 1.
- Have a life expectancy of at least 3 months.
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- For Ib dose expansion part and not mandatory for Ia dose escalation part: Subjects with R/R NHL must have measurable lesions as defined by Lugano 2014 criteria. Subjects with advanced solid tumors must have measurable or evaluable lesions as defined by RECIST 1.1.
- Adequate organ and bone marrow functions.
- The adequate washout period for prior therapy .
- Subjects must use a highly effective contraception method throughout the study and for 3 months after discontinuation of the study drug.
- Signed ICF and willing to comply with all the requirements in the protocol.
Who cannot join
- Diagnosis of precursor B-cell lymphoblastic leukemia/lymphoma, precursor T-cell lymphoblastic leukemia/lymphoma, precursor NK cell lymphoblastic leukemia/lymphoma. Diagnosis of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL).
- Central nervous system infiltration.
- Uncontrolled or significant cardiovascular disease.
- Major surgery within 4 weeks before the first dose of study drug.
- Known or suspected hypersensitivity to AXT-1003 or any of the excipients.
- Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of AXT-1003.
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- History of other malignancies prior to enrollment; except for subjects with basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or other carcinomas in situ who have undergone possible curative treatment and do not have disease recurrence within 5 years since starting the treatment.
- Any prior treatment-related clinically significant toxicities that have not resolved to Grade ≤ 1 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
- Active infection requiring systemic treatment.
- Infection with hepatitis B virus with positive hepatitis B surface antigen, or hepatitis C virus with detectable anti-hepatitis C circulating viral RNA.
- Subjects known to be infected with human immunodeficiency virus and active tuberculosis.
- Females who are pregnant or breastfeeding.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
- Recruiting
Hunan Cancer Hosptial
Changsha
- Recruiting
Fujian Cancer Hospital
Fuzhou
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
About this study
Official title: An Open-label, Multicenter, Phase I Safety Study of AXT-1003 in Subjects With Advanced Malignant Tumors
This is a Phase I study of AXT-1003 to assess the safety, tolerability, and pharmacokinetics in patients with advanced malignancies.
Read the detailed description
AXT1003-1102 is a multicenter, open-label, Phase I safety study of AXT-1003 in patients with advanced malignancies. It is designed to observe the safety of AXT-1003 in patients with advanced malignancies, determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), evaluate the pharmacokinetic profile, and explore the preliminary antitumor activity.
- Conditions
- Non-Hodgkin Lymphoma, Advanced Solid Tumor
- Being tested
- AXT-1003
- Keywords
- AXT-1003, EZH2, Phase I, Advanced malignancies
- 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.
AXT-1003Drug
AXT-1003 capsule is administered orally daily, until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| AXT-1003 | Experimental | Dose Escalation: Part A:
Level 1 (Starting Dose) Oral AXT-1003 5 mg BID; Level 2 Oral AXT-1003 10mg BID; Level 3 Oral AXT-1003 15mg BID ; Level 4 Oral AXT-1003 20mg BID; Level 5 Oral AXT-1003 25mg BID; Level 6 Oral AXT-1003 30mg BID; Level 7 Oral AXT-1003 35mg BID; Level 8 Oral AXT-1003 40mg BID;
Dose Escalation: Part B:
Oral AXT-1003 2.5mg QD, 10mg BID;
Dose Expansion: 1 or 2 cohorts at the dose levels selected from dose escalation part Receives: Drug: AXT-1003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicity (DLT) (Dose Escalation)
Dose Escalation only: to characterize the dose limiting toxicities (DLTs) of AXT-1003.
Measured: Up to 28 days
Number of Participants with Adverse Events (AEs)
Laboratory test ,ECG, vital signs, physical examination
Measured: Baseline up to 30 days after the last dose of study
Secondary outcomes (11)
Overall response rates (ORR)
ORR is defined as the proportion of subjects with a CR or PR.
Measured: Up to 3 years
Duration of response(DOR)
DOR is defined as the time from the initial objective response to progression of disease (PD) or death after the response, whichever occurs first.
Measured: Up to 3 years
Progression free survival (PFS)
Progression-free survival is defined as the time from the first dose of study treatment to the first PD or death for any reason in the absence of documented PD, whichever occurs first.
Measured: Up to 3 years
Time to response (TTR)
Time to response is defined as the time from first dose of study treatment to the first objective tumor response.
Measured: Up to 3 years
Disease control rate (DCR)
Disease control rate is defined as the proportion of subjects with a CR, PR, or stable disease(SD).
Measured: Up to 3 years
Maximum observed concentration (Cmax) of AXT-1003
Pharmacokinetics of AXT-1003
Measured: Up to 15 days
Time of maximum observed concentration (tmax) of AXT-1003
Pharmacokinetics of AXT-1003
Measured: Up to 15 days
Area under the curve from the time of dosing to the time of the last measurable concentration (AUCtau) of AXT-1003
Pharmacokinetics of AXT-1003
Measured: Up to 15 days
Minimum observed concentration (Cmin) of AXT-1003
Pharmacokinetics of AXT-1003
Measured: Up to 15 days
Terminal elimination half-life (t1/2) of AXT-1003
Pharmacokinetics of AXT-1003
Measured: Up to 15 days
Total body clearance (CL/F) of AXT-1003
Pharmacokinetics of AXT-1003
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start4 Sep 2024
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axter Therapeutics (Beijing) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qian Gao, Study director, Axter Therapeutics (Beijing) Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484985
- Sponsor's protocol ID
- AXT1003-1102
- Status last verified
- Jan 2026
- First submitted
- 26 Jun 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase I Safety Study of AXT-1003 in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT06484985
- Acronym / sponsor ID
- AXT1003-1102
- Conditions
- Non-Hodgkin Lymphoma, Advanced Solid Tumor
- Keywords
- AXT-1003, EZH2, Phase I, Advanced malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Axter Therapeutics (Beijing) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Jul 2024 (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 a Phase I study of AXT-1003 to assess the safety, tolerability, and pharmacokinetics in patients with advanced malignancies.
Detailed description
AXT1003-1102 is a multicenter, open-label, Phase I safety study of AXT-1003 in patients with advanced malignancies. It is designed to observe the safety of AXT-1003 in patients with advanced malignancies, determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), evaluate the pharmacokinetic profile, and explore the preliminary antitumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AXT-1003 | Experimental | Drug: AXT-1003Dose Escalation: Part A: Level 1 (Starting Dose) Oral AXT-1003 5 mg BID; Level 2 Oral AXT-1003 10mg BID; Level 3 Oral AXT-1003 15mg BID ; Level 4 Oral AXT-1003 20mg BID; Level 5 Oral AXT-1003 25mg BID; Level 6 Oral AXT-1003 30mg BID; Level 7 Oral AXT-1003 35mg BID; Level 8 Oral AXT-1003 40mg BID; Dose Escalation: Part B: Oral AXT-1003 2.5mg QD, 10mg BID; Dose Expansion: 1 or 2 cohorts at the dose levels selected from dose escalation part |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- For Ia dose escalation part only:
- R/R NHL: Locally histopathological diagnosis of relapsed/refractory non-Hodgkin lymphoma (R/R NHL), who have progressed or been intolerant after the available standard therapies, or have no access to the standard therapies.
- Advanced solid tumors: Locally histopathological diagnosis of locally advanced unresectable and metastatic solid tumors,The above subjects have progressed or been intolerant after the available standard therapies, or have no access to the standard therapies.
- For Ib dose expansion part only: Subjects with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL)
- Eastern Cooperative Oncology Group (ECOG) performance status scale 0 to 1.
Key exclusion criteria (12 listed)
- Diagnosis of precursor B-cell lymphoblastic leukemia/lymphoma, precursor T-cell lymphoblastic leukemia/lymphoma, precursor NK cell lymphoblastic leukemia/lymphoma. Diagnosis of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL).
- Central nervous system infiltration.
- Uncontrolled or significant cardiovascular disease.
- Major surgery within 4 weeks before the first dose of study drug.
- Known or suspected hypersensitivity to AXT-1003 or any of the excipients.
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 |
|---|---|---|
| AXT-1003AXT-1003 capsule is administered orally daily, until disease progression or intolerable toxicity. | Drug | AXT-1003 |
Primary outcome
Number of Participants With Dose-Limiting Toxicity (DLT) (Dose Escalation)
Time frame: Up to 28 days
Dose Escalation only: to characterize the dose limiting toxicities (DLTs) of AXT-1003.
Number of Participants with Adverse Events (AEs)
Time frame: Baseline up to 30 days after the last dose of study
Laboratory test ,ECG, vital signs, physical examination
11 secondary outcomes
Overall response rates (ORR)
Time frame: Up to 3 years
Duration of response(DOR)
Time frame: Up to 3 years
Progression free survival (PFS)
Time frame: Up to 3 years
Time to response (TTR)
Time frame: Up to 3 years
Disease control rate (DCR)
Time frame: Up to 3 years
Maximum observed concentration (Cmax) of AXT-1003
Time frame: Up to 15 days
Time of maximum observed concentration (tmax) of AXT-1003
Time frame: Up to 15 days
Area under the curve from the time of dosing to the time of the last measurable concentration (AUCtau) of AXT-1003
Time frame: Up to 15 days
Minimum observed concentration (Cmin) of AXT-1003
Time frame: Up to 15 days
Terminal elimination half-life (t1/2) of AXT-1003
Time frame: Up to 15 days
Total body clearance (CL/F) of AXT-1003
Time frame: Up to 15 days
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 28 Jan 2026.
- 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.
Qian Gao study director
Axter Therapeutics (Beijing) Co., Ltd
5 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 AXT-1003 in people with Non-Hodgkin Lymphoma and Advanced Solid Tumor, run by Axter Therapeutics (Beijing) Co., Ltd at 5 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 11 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
Contact Wilson Wang (+86 10 65120010, wilson.wang@axtertx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-Limiting Toxicity (DLT) (Dose Escalation) (time frame: Up to 28 days). 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 28 Jan 2026.