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Advanced TumorPhase 1/2NCT06558513

To Evaluate a Phase I/II Clinical Study of XNW5004 Tablets in Patients With Relapsed/Refractory Advanced Tumors

A Phase 1/2 study testing XNW5004 tablets in people with Advanced Tumor and Lymphoma, run by Evopoint Biosciences Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with advanced tumors diagnosed histologically or cytologically at the study center who were refractory to standard therapy or had relapsed received XNW5004 tablets Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Tumor, Lymphoma
What is being tested?
XNW5004 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
3 Aug 2021to 30 Aug 2025
Phase
Phase 1/2
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

  • Age: ≥ 18 years old; Gender unlimited
  • Pathologically confirmed, relapsed or refractory non Hodgkin's lymphoma (NHL). The definition of recurrence and refractory is as follows: Recurrence: After achieving remission, NHL meets the conditions for disease progression. For B-NHL patients, they should undergo a two line drug treatment regimen (with the first line containing CD20 monoclonal antibody), or a second line systemic treatment regimen that is not suitable/tolerated (such as toxic side effects, etc.); For T-NHL, first-line systemic chemotherapy should be administered, or if systemic chemotherapy is intolerant, and a regimen containing targeted CD30 drugs (including but not limited to Vibutuximab) or cetuximab should be administered. Refractory: Systemic medication treatment with at least two regimens and a total course of no less than 4 cycles of dose standard has not achieved partial remission.
  • Only limited to stage IIa, pathologically diagnosed, relapsed or refractory follicular lymphoma, peripheral T-cell lymphoma, and diffuse large B-cell lymphoma, with recurrence and refractory defined according to inclusion criteria 2: Cohort 1: Follicular lymphoma (EZH2 mutant): Subjects whose genetic testing results showed the presence of EZH2 gene mutations; If the subject is unable to provide previous genetic testing results or there is no EZH2 gene mutation information in the previous genetic testing results, tumor tissue samples or bone marrow samples (only for subjects with bone marrow invasion) and blood samples must be provided. Only after confirming the presence of EZH2 gene mutations in the central laboratory can they be included in this queue; Cohort 2: Follicular lymphoma (EZH2 wild-type): subjects whose genetic testing results showed no EZH2 gene mutations; If the subject is unable to provide previous genetic testing results or there is no EZH2 gene mutation information in the previous genetic testing results, tumor tissue samples or bone marrow samples (only for subjects with bone marrow invasion) and blood samples must be provided. Only after confirmation by the central laboratory that there is no EZH2 gene mutation can they be included in this queue; Cohort 3: Peripheral T-cell lymphoma, according to the 2016 WHO classification of lymphoid tissue tumors; Cohort 4: Diffuse large B-cell lymphoma;
  • At least one measurable lesion should be used as the evaluation basis
  • During the dose escalation phase, subjects should provide tumor tissue samples or bone marrow samples (limited to subjects with bone marrow invasion) and oral swabs (control samples) as much as possible. If tumor tissue or bone marrow samples cannot be provided, they can be included in the study after evaluation by the researcher, provided that they meet other inclusion criteria;
  • Has a life expectancy of ≥12 weeks;
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  • The ECOG score is 0-1;
  • The functional reserve of important organs meets the following requirements: (1) Hematopoietic function: a) Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L (≥ 0.5 × 10^9/L for those with bone marrow infiltration) (G-CSF was not used within one week before the screening period blood routine examination, and long-acting white needle was not used within two weeks); b) Platelet count ≥ 75 × 10^9/L (≥ 50 × 10^9/L for those with bone marrow infiltration) (no platelet transfusion or TPO receptor agonist used within one week before the screening period blood routine examination); c) Hemoglobin ≥ 90 g/L (bone marrow infiltration requires ≥ 70 g/L) (no red blood cells were transfused or EPO was used within one week before the screening period blood routine examination); (2) Liver function: serum total bilirubin ≤ 1.5 x ULN (Gilbert's syndrome ≤ 3 ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN, ALT/AST ≤ 5 x ULN for patients with liver infiltration, and alkaline phosphatase ≤ 5 x ULN for patients with liver and/or bone infiltration; (3) Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate estimated based on Cockcroft Gault formula ≥ 60 mL/min (Cockcroft Gault formula, see Appendix 5 for details); (4) Left ventricular ejection fraction (LVEF) ≥ 50%; (5) International standardized ratio (INR) or plasma prothrombin time (PT) ≤ 1.5 x ULN, partial thromboplastin time (APTT) ≤ 1.5 x ULN.
  • Non surgical sterilization or female patients of childbearing age, as well as male subjects whose partners are female of childbearing age, are required to use a medically approved contraceptive measure (such as an intrauterine device, contraceptive pill, or condom) within 6 months after the screening period and the end of the study treatment period; Non surgically sterilized female patients of childbearing age must have a negative serum HCG test within 7 days prior to enrollment in the study, and must be non lactating;
  • Prior to conducting research specific procedures, provide a written informed consent form with a signature and date, and be able to comply with clinical visits and research related procedures.

Who cannot join

  • Patients who have previously received treatment with drugs similar or related to the investigational drug pathway (such as EZH 1/2 or EZH2 inhibitors);
  • Those who have received anti-tumor treatment in the early stage but have not recovered their toxicity (according to NCI-CTCAE 5.0, the toxicity has not recovered to ≤ 1 level). Other toxicities that the researchers believe do not affect the safety evaluation of the subjects, such as hair loss, are excluded;
  • Have a history of other malignant tumors within the 5 years prior to enrollment and do not meet clinical cure criteria. The following cases are excluded: skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast intraductal carcinoma in situ and thyroid papillary carcinoma that can be treated locally and have been cured.
  • Impaired heart function or clinically severe heart disease, including any of the following: (1) Acute myocardial infarction or unstable angina before first administration ≤ 6 months; (2) Congestive heart failure (New York Heart Association classification of heart function as III or IV); (3) Uncorrected severe arrhythmia and hypertension ≥ 150/100mmHg; (4) Extended QTc interval (defined as>450ms in males and>470ms in females) (Fredericia's formula); (5) Have a history of other major cardiovascular diseases (such as valve replacement surgery, coronary artery bypass grafting surgery, etc.).
  • Severe systemic active infection;
  • HIV positive and syphilis (Anti TB) positive individuals;
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  • HBsAg positive and HBV-DNA copy number higher than the normal upper limit of detection value; Or HBcAb positive and HBV-DNA copy number higher than the normal upper limit of detection value; HCV antibody is positive, and the copy number of HCV RNA is higher than the normal upper limit of the detection value;
  • There is a history of COVID-19 vaccination within one month before the first administration of this test, and there is a history of other vaccines within three months before the first administration of this test;
  • Subjects who are known to be allergic to the investigational drug or its active ingredients or excipients;
  • Patients who have undergone major surgery within 4 weeks prior to the start of treatment or plan to undergo major surgery during this study period (excluding surgeries such as puncture or lymph node biopsy);
  • The subject is unable to swallow, or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or has undergone gastrectomy or gastric banding that affects drug absorption. But gastroesophageal reflux disease that has been treated with proton pump inhibitors is allowed (if there is no possibility of drug interaction);
  • Subjects who took known CYP3A4 inhibitors/inducers within 14 days prior to the first administration (see Appendix 7 for details);
  • History of having T-cell lymphoblastic lymphoma (T-LBL) or T-cell lymphoblastic leukemia (T-ALL);
  • Any history of malignant myeloid tumors, including myelodysplastic syndrome (MDS), or abnormal detection indicators related to MDS or myeloproliferative tumors (MPN);
  • Individuals with a history of abuse or drug use of psychotropic substances;
  • It is known that the subjects have bleeding prone diseases such as von Willebrand's disease or hemophilia, or require long-term treatment with warfarin or other vitamin K antagonists (such as phenylpropanoid coumarin);
  • Individuals who may not be able to complete this study due to other reasons or whom the researcher believes should not be included.
  • Previously suffering from or accompanied by central nervous system disorders, including but not limited to: epilepsy, paralysis, stroke, severe brain injury, senile dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, mental illness, etc;
  • The presence of central nervous system or testicular invasion;
  • Stage IIa only: follicular lymphoma grade 3b, mixed histology, or follicular lymphoma histologically transformed into diffuse large B-cell lymphoma;
  • Stage IIa only: Diffuse large B-cell lymphoma diagnosed by FISH testing with MYC, BCL-2, and/or BCL-6 rearrangement;
  • Stage IIa only: mycosis fungoides, S é zary syndrome, and primary cutaneous enlarged T-cell lymphoma;
  • Burkitt's lymphoma, a gray area lymphoma between diffuse large B-cell lymphoma and Burkitt's lymphoma, and a gray area lymphoma between diffuse large B-cell lymphoma and Hodgkin's lymphoma;
  • Previously received organ transplantation or allogeneic hematopoietic stem cell transplantation (ALLo HSCT);
  • Auto-HSCT (autologous hematopoietic stem cell transplantation) was performed within 3 months prior to administration in this experiment;
  • Immunosuppressants are being used, including but not limited to: cyclosporine, tacrolimus, etc. used within 2 weeks prior to administration in this trial; Within 7 days before administration, receive high-dose corticosteroids (prednisone with a daily dose greater than 10mg or equivalent doses of other corticosteroids);
  • Received radiotherapy within 4 weeks prior to administration in this trial;
  • Received anti-tumor treatments such as chemotherapy, targeted therapy, and anti-tumor traditional Chinese medicine within 4 weeks prior to administration in this trial;
  • Received immunotherapy within 4 weeks prior to administration in this trial;
  • Received CAR-T treatment within 12 weeks prior to administration in this trial;
  • Those who have used any other clinical trial drugs within 4 weeks prior to the administration of this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hematology Hospital, Chinese Academy of Medical Sciences

    Tianjin

Other trials in China

About this study

Official title: Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Initial Efficacy of XNW5004 Tablets in Patients With Relapsed/Refractory Advanced Tumors

Patients with advanced tumors diagnosed histologically or cytologically at the study center who were refractory to standard therapy or had relapsed received XNW5004 tablets

Being tested
XNW5004 tablets
Keywords
EZH2 inhibitor, XNW5004
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XNW5004 tabletsDrug

    XNW5004 an EZH2 inhibitor, BID, administered in continuous

Study groups in NCT06558513
Study groupRoleWhat they receive
XNW5004ExperimentalPhase 1：treated with escalated doses of XNW5004 respectively； Phase 2：treated with RP2D of XNW5004 respectively
Receives: Drug: XNW5004 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of treatment-emergent adverse events (AEs)[Safety and Tolerability]

    The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of XNW5004 will be assessed.

    Measured: through study completion, an average of about 10 months

  2. Recommended phase 2 dose (RP2D)

    Recommended phase 2 dose (RP2D) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of XNW5004.

    Measured: 28 days since the date of first dose in phase 1

Secondary outcomes (11)

  1. Time to peak (Tmax)

    Pharmacokinetics profile of a single dose and continuous medication of XNW5004 and its metabolite (plasma): Time to peak (Tmax) of plasma concentration

    Measured: 28 days since the date of first dose

  2. Maximum plasma concentration (Cmax)

    Pharmacokinetics profile of a single dose and continuous medication of XNW5004 and its metabolite (plasma): Maximum plasma concentration (Cmax)

    Measured: 28 days since the date of first dose

  3. Halflife (T1/2)

    Pharmacokinetics profile of a single dose and continuous medication of XNW5004 and its metabolite (plasma): Halflife (T1/2)

    Measured: 28 days since the date of first dose

  4. Objective response rate (ORR)

    Assess the response rate of subjects to the treatment of XNW5004

    Measured: every 8 weeks through study completion, an average of about 10 months

  5. Progression-free survival (PFS)

    Assess the progression-free survival of the subjects after the treatment of XNW5004

    Measured: every 8 weeks through study completion, an average of about 10 months

  6. Duration of Response (DoR)

    Assess the duration of Response of the subjects after the treatment of XNW5004

    Measured: every 8 weeks through study completion, an average of about 10 months

  7. Complete response rate (CRR)

    Assess the Complete response rate of the subjects after the treatment of XNW5004

    Measured: every 8 weeks through study completion, an average of about 10 months

  8. Partial response rate (PRR)

    Assess the partial response rate of the subjects after the treatment of XNW5004

    Measured: every 8 weeks through study completion, an average of about 10 months

  9. Disease control rate (DCR)

    Assess the disease control rate of the subjects after the treatment of XNW5004

    Measured: every 8 weeks through study completion, an average of about 10 months

  10. The correlation between potential biomarkers (including but not limited to EZH2 mutations, etc.) and therapeutic efficacy

    Assess the correlation between potential biomarkers (including but not limited to EZH2 mutations, etc.) and therapeutic efficacy of the subjects after the treatment of XNW5004

    Measured: every 8 weeks through study completion, an average of about 10 months

  11. H3K27me3 (H3 histone 27th lysine trimethylation)/H3 histone relative baseline change level

    Assess the H3K27me3 (H3 histone 27th lysine trimethylation)/H3 histone relative baseline change level of the subjects after the treatment of XNW5004

    Measured: 28 days since the date of first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2024
  2. Study start3 Aug 2021
  3. Primary completion30 Aug 2025
  4. Study completion30 Aug 2025

Resources

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
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06558513
Sponsor's protocol ID
XNW5004-I/II-01
Status last verified
Oct 2026
First submitted
14 Aug 2024
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing XNW5004 tablets in people with Advanced Tumor and Lymphoma, run by Evopoint Biosciences Inc. 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 10 inclusion and 31 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 20 Oct 2026. 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 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?

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?

Incidence and severity of treatment-emergent adverse events (AEs)[Safety and Tolerability] (time frame: through study completion, an average of about 10 months). 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?

On the ClinicalTrials.gov record for NCT06558513.

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 20 Oct 2026.

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