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

NCT06702605 | Not Yet Recruiting Phase 2

• 1 other identifier: XNW5004-II-02
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Relapsed/Refractory Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) assessed by independent review committee (IRC)

  Percentage of participants achieving complete response (CR) and partial response (PR) in the study.

  24 mounths

Secondary Outcomes (5)

• ORR assessed by investigator

  24 mounths

• Progression free survival

  24 mounths

• Time to Response

  around 4 months

• Duration of response

  24 mounths

• Overall survival

  around 5 years

Study Arms (1)

XNW5004

EXPERIMENTAL

XNW5004 tablets Oral administration, twice daily, with a 28-day continuous dosing as one cycle.

Drug: XNW5004 tablets

Interventions

XNW5004 tablets DRUG

XNW5004 will be administered orally as tablets.

XNW5004

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able to provide written informed consent form prior to the commencement of any study activity/procedure.

You may not qualify if:

• 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.
• Subjects who have received anti-tumor therapy in the early stage and have not recovered from toxicity (toxicity has not recovered to ≤ Grade 1 according to NCI-CTCAE 5.0). Except for other toxicities (such as alopecia, etc.) that do not affect the safety evaluation of subjects in the opinion of the investigator.
• Subjects with history of other malignancies within 3 years prior to enrollment and not meeting clinical cure criteria. Exceptions are the following: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, and papillary carcinoma of the thyroid that can be treated locally.
• Subjects with mycosis fungoides, Sézary syndrome, or primary cutaneous T-cell lymphoma.
• Subjects with previous or current central nervous system invasion.
• Subjects with previous or current testicular or breast invasion.

Sponsors & Collaborators

• Evopoint Biosciences Inc.: lead

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhiming Li M.D.

CONTACT

13719189172; lizhm@sysucc.org.cn

Hui Zhou M.D.

CONTACT

13975879796; zhouhui@hnca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11