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To Evaluate XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma | Clinical Trials | Clareo Health

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To Evaluate XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma

A Phase II Clinical Study of XNW5004 Tablets in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma

NCT06702605•Evopoint Biosciences Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, multi-center clinical study to evaluate the efficacy and safety of XNW5004 tablets in subjects with R/R PTCL. The study plans to enroll approximately 50 subjects.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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 \>=2 prior systemic treatment lines, including at least one new drug; subjects with CD30 positive ALCL requires 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 as defined in the following requirements.
•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.
+1 more criteria

Exclusion Criteria

•Prior exposure to EZH2 inhibitor(s) or EZH1/2 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.
•Subjects with a history of psychotropic drug abuse or drug abuse.
+24 more criteria

Key Dates

Start Date

November 1, 2024

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2027

Last Updated

November 25, 2024

Enrollment

ESTIMATED participants

Conditions

Relapsed/Refractory Peripheral T Cell Lymphoma

Interventions

XNW5004 tablets

DRUG

Contacts

Zhiming Li M.D.

CONTACT

13719189172 lizhm@sysucc.org.cn

Hui Zhou M.D.

CONTACT

13975879796 zhouhui@hnca.org.cn