A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Evopoint Biosciences Inc.2 sites in 1 country120 target enrollmentApril 10, 2025

InterventionsXNW5004 ; Chidamide placebo XNW5004 placebo; Chidamide

DrugsXNW5004 ; Chidamide placebo XNW5004 placebo; Chidamide

Overview

Phase: Phase 3
Intervention: XNW5004 ; Chidamide placebo
Conditions: Not specified
Sponsor: Evopoint Biosciences Inc.
Enrollment: 120
Locations: 2
Primary Endpoint: Progression Free Survival (PFS) assessed by BICR
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, multi-center, phase III clinical trial designed to evaluate the efficacy of XNW5004 tablets versus Chidamide in Relapsed/Refractory PTCL, with a target of enrolling 120 subjects.

Registry

clinicaltrials.gov

Start Date

April 10, 2025

End Date

April 1, 2028

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Evopoint Biosciences Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 18-70 years (inclusive)，gender not limited.
•Pathologically diagnosed, relapsed or refractory peripheral T-cell lymphoma.
•Disease status defined as relapsed or refractory after \>=1 prior systemic treatment lines, and have not received treatment with HDAC inhibitors, subjects with NK/T-cell lymphoma require treatment with a regimen containing asparaginase/protease, subjects with CD30 positive ALCL require prior treatment with Brentuximab vedotin.
•Subjects who have received prior radiotherapy are allowed to enroll, but radiotherapy alone is not considered a systemic therapy.
•Having at least one measurable lesion for evaluation.
•Agree to provide archived tumor tissue samples or fresh tumor tissue samples that meet the requirements.
•Life expectancy of at least 12 weeks.
•Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
•Have adequate organ function.
•Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.Non-sterile subjects must be willing to use a highly effective contraception (e.g., IUD, pill, or condom) for the duration of the study and for 6 months after the last dose of study drug unless their partner is sterilized. For male subjects whose partner is a woman of childbearing potential, surgical sterilization or agreement to use effective contraception for the duration of the study and for 6 months after the last dose of study drug is required. In addition, males must agree not to donate sperm during the study participation and for at least 6 months after the last dose of study drug.

Exclusion Criteria

•Prior exposure to EZH2 inhibitor(s) or EZH1/2 inhibitor(s).
•Prior exposure to HDAC inhibitor(s).
•Subjects with known hypersensitivity to the study drug or its active ingredients or excipients.
•Subjects who have received anti-tumor therapy, such as chemotherapy, immunotherapy, radiotherapy, and targeted therapy, within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, received CAR-T therapy within 12 weeks prior to the first dose of the study drug, autologous hematopoietic stem cell transplantation (Auto-HSCT) within 3 months prior to the first dose of the study drug.
•Subjects who have received other anti-tumor investigational drug treatment within 28 days prior to the first dose of XNW5004 in this study.
•Subjects who have undergone major surgery within 4 weeks prior to the start of study treatment or who intend to undergo major surgery during this study (except for procedures such as puncture or lymph node biopsy).
•Subjects who have an allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
•Subjects who have received systemic treatment with corticosteroids (prednisone at a dose of \> 10 mg per day or equivalent doses of other glucocorticoids) or other immunosuppressive drugs within 14 days prior to the use of the study drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with prednisone at a dose of ≤ 10 mg per day or equivalent doses of other glucocorticoids are permitted.
•Subjects taking known strong CYP3A4 inhibitors/inducers and P-glycoprotein (P-gp) inhibitors within 14 days prior to the first dose.
•Subjects who have received live virus vaccines (including live attenuated vaccines) within 28 days prior to dosing. Inactivated vaccines are permitted.