Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma

NCT07730515 | Recruiting Phase 1

• 1 other identifier: XNW5004-Ib/II-05
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the XNW5004 tablets combined with CHOP/CHOEP will be used for the treatment of newly diagnosed PTCL patients.

Conditions

Non-hodgkin Lymphoma; Peripheral T-cell Lymphoma

Keywords

EZH2 inhibitor; XNW5004

Outcome Measures

Primary Outcomes (3)

• Ib/II:Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability].

  Incidence and severity of adverse events that are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

  through study completion, an average of 1 year

• II：Objective response rate (ORR)

  ORR is defined as the proportion of subjects who have a confirmed CR or a PR per lugano2014 assessed by Investigator.

  36 months

• Ib:Maximum tolerated dose (MTD) and/or the recommended Part 2 dose

  To determine the maximum tolerated dose (MTD) and the recommended Part 2 dose with XNW5004.

  The first 21-day cycle of therapy

Secondary Outcomes (13)

• Ib/II:The maximum (peak) blood drug concentration (Cmax) is XNW5004

  through study completion, an average of 1 year

• Ib/II：XNW5004 Peak Time (Tmax)

  through study completion, an average of 1 year

• Ib/II：The area under the blood drug concentration-time curve of XNW5004 (AUC)

  through study completion, an average of 1 year

• Ib/II:The maximum (peak) blood drug concentration in the steady state (Css,max)

  through study completion, an average of 1 year

• Ib/II:XNW5004 Steady-state Baseline Concentration (Css, min)

  through study completion, an average of 1 year

Study Arms (4)

Ib stage,Cohort1

EXPERIMENTAL

Phase of dose escalation for the XNW5004 tablet in combination with CHOP regimen.

Drug: XNW5004 combined with CHOP (incremental)

Ib stage,Cohort2

EXPERIMENTAL

Phase of dose escalation for the XNW5004 tablet in combination with CHOEP regimen

Drug: XNW5004 combined with CHOEP (incremental)

Phase II, dose expansion stage,CHOP

EXPERIMENTAL

XNW5004 combined with CHOP

Drug: XNW5004 combined with CHOP (extended)

Phase II, dose expansion stage,CHOEP

EXPERIMENTAL

XNW5004 combined with CHOEP

Drug: XNW5004 combined with CHOEP (extended)

Interventions

XNW5004 combined with CHOP (incremental) DRUG

The XNW5004 protocol has preset four dosage groups: 400mg, 800mg, 1200mg and 1600mg, administered twice daily (BID). The CHOP regimen is administered at a fixed dose, for a total of 6 cycles. After completing the combined treatment and without disease progression, the subjects will continue to receive XNW5004 at 1200mg BID for maintenance therapy.

Also known as: cyclophosphamide, doxorubicin, vincristine, prednisone acetate tablet, XNW5004

Ib stage,Cohort1

XNW5004 combined with CHOEP (incremental) DRUG

It is expected to conduct dose escalation studies for XNW5004 in combination with CHOEP using 1-3 dose groups. The CHOEP regimen will be administered at a fixed dose for a total of 6 cycles. After completing the combined treatment and without disease progression, the subjects will continue to receive XNW5004 at 1200mg BID for maintenance therapy.

Also known as: XNW5004, cyclophosphamide, doxorubicin, vincristine, prednisone acetate tablet, etoposide

Ib stage,Cohort2

XNW5004 combined with CHOP (extended) DRUG

Those who received the combination treatment of XNW5004 and CHOP, and who did not experience disease progression after the combined treatment, will continue to receive maintenance treatment with XNW5004 at a dose of 1200mg twice daily.

Also known as: XNW5004, cyclophosphamide, doxorubicin, vincristine, prednisone acetate tablet

Phase II, dose expansion stage,CHOP

XNW5004 combined with CHOEP (extended) DRUG

Those who received the combination treatment of XNW5004 and CHOEP, and who did not experience disease progression after the combined treatment, will continue to receive maintenance treatment with XNW5004 at a dose of 1200mg twice daily.

Also known as: cyclophosphamide, doxorubicin, vincristine, prednisone acetate tablet, etoposide

Phase II, dose expansion stage,CHOEP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years (inclusive); both genders are eligible.
• Pathologically confirmed peripheral T-cell lymphoma (PTCL).
• No prior systemic anti-PTCL therapy.
• At least one measurable lesion as the basis for evaluation: nodal lesions with a long diameter \> 1.5 cm; extranodal lesions with a long diameter \> 1.0 cm.
• Life expectancy of at least 12 weeks.
• ECOG performance status score of 0-1.
• Vital organ function reserves meet the following requirements:
• Hematopoietic function:
• White blood cell count \>= 3.5 x 10\^9/L (no G-CSF administration within 1 week before the screening blood test, and no long-acting leukocyte-elevating agent administration within 2 weeks)
• Platelet count \>= 75 x 10\^9/L (no platelet transfusion or TPO receptor agonist administration within 1 week before the screening blood test)
• Hemoglobin \>= 80 g/L (no red blood cell transfusion or EPO administration within 1 week before the screening blood test)
• Hepatic function: serum total bilirubin \<= 1.5 x ULN (\<= 3 x ULN for Gilbert's syndrome), and ALT and AST \<= 2.5 x ULN; for subjects with liver infiltration, ALT/AST \<= 5 x ULN; for subjects with liver and/or bone infiltration, alkaline phosphatase \<= 5 x ULN
• Renal function: serum creatinine \<= 1.5 x ULN or estimated creatinine clearance \>= 60 mL/min according to the Cockcroft-Gault formula
• Left ventricular ejection fraction (LVEF) \>= 50%
• International normalized ratio (INR) \<= 1.5 x ULN, or prothrombin time (PT) and activated partial thromboplastin time (APTT) \<= 1.5 x ULN

You may not qualify if:

• Prior treatment with any anti-tumor therapy, including but not limited to: chemotherapy, immunotherapy, radiotherapy, targeted therapy, anti-tumor traditional Chinese medicine, or anti-tumor investigational drugs.
• Subjects with known hypersensitivity to the investigational drug or its active ingredients or excipients.
• Subjects who have undergone major surgery within 4 weeks prior to the first dose of the investigational drug, or who plan to undergo major surgery during the study period (except for procedures such as puncture or lymph node biopsy).
• Prior or planned allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
• Receipt of steroid hormones for anti-tumor purposes (daily dose \> 20 mg prednisone or equivalent dose of other glucocorticoids) within 7 days prior to the first dose of the investigational drug; or diseases requiring systemic treatment with steroid hormones (daily dose \> 10 mg prednisone or equivalent dose of other glucocorticoids) or other immunosuppressive drugs within 14 days prior to the first dose of the investigational drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with a daily dose \<= 10 mg prednisone or equivalent dose of other glucocorticoids are permitted.
• Subjects who have taken known moderate or strong CYP3A4 inhibitors/inducers within 14 days prior to the first dose.
• Receipt of live virus vaccine (including attenuated live vaccine) within 28 days prior to dosing. Inactivated vaccines are permitted.
• History of psychotropic substance abuse or drug addiction.
• History of other malignancies within 3 years prior to enrollment that do not meet clinical cure criteria. The following are exceptions: basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and has been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
• Mycosis fungoides, Sezary syndrome, and primary cutaneous T-cell lymphoma.
• Presence of central nervous system involvement.
• Presence of testicular or breast involvement.
• Prior or current hemophagocytic syndrome.
• Prior or current immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia, or other primary or secondary hematological diseases that may affect bone marrow function other than the primary malignancy.
• Prior or current acute myeloid leukemia (AML).

Sponsors & Collaborators

• Evopoint Biosciences Inc.: lead

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, T-Cell, Peripheral

Interventions

Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Etoposide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides

Central Study Contacts

Linlin.li Li

CONTACT

18678888561; linlin.li@evopointbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 28, 2026
• Study Start: August 15, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)