EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors

Официальное название

A Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, and Initial Efficacy of EVM16 Injection as a Single and Combination With Tislelizumab in Subjects With Advanced or Recurrent Solid Tumors

Обзор

The goal of this clinical trial is to learn the side effects, safety and effect of a tumor vaccine (EVM16) alone or in combined with an anti-PD-1 antibody (tislelizumab) . This clinical trial will include solid tumor patients who failed standard treatment. The main questions to answer are: Safety of EVM16. Suitable dose of EVM16. Effects of EVM16 combined with tislelizumab.

Вмешательства

• Биопрепарат EVM16
  cancer vaccine
• Препарат Tislelizumab
  Anti-PD1 antibody

Первичные конечные точки

• safety and tolerability [Срок оценки: From the first study intervention to 90 days after the last study intervention.]
• RP2D for EVM16 [Срок оценки: During the intervention, up to approximately 1 year.]

Вторичные конечные точки (6)

• immunogenicity of EVM16 [Срок оценки: during the intervention, up to 1 year]
• objective response rate (ORR) of EVM16 in combination with tislelizumab [Срок оценки: From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first.]
• disease control rate (DCR) of EVM16 in combination with tislelizumab [Срок оценки: From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first.]
• duration of disease remission (DOR) of EVM16 in combination with tislelizumab [Срок оценки: From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first.]
• time to remission (TTR) of EVM16 in combination with tislelizumab [Срок оценки: From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first.]
• PFS of EVM16 in combination with tislelizumab （Only in phase Ib） [Срок оценки: From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first]

Критерии участия

Критерии включения

• Recurrent or metastatic solid tumors that have been histologically or cytologically pathologically confirmed and are not amenable to radical treatment with surgery or local therapy.
• Patients with advanced or recurrent solid tumors who have failed prior standard therapy.
• Expected survival period >6 weeks at the time of informed consent.
• Adequate organ function
• Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0 to 1.
• Is willing to provide archival or fresh tumor tissue samples for EVM16 production.
• Has adequate treatment washout period prior to first study dose.
• Has at least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria before enrollment.

Критерии исключения

• Primary central nervous system (CNS) malignancies that are symptomatic, untreated, or in need of curative treatment, or subjects with CNS metastases.
• Uncontrolled co-morbidities.
• Cerebrovascular event (stroke, transient ischemic attack, etc.) within 4 months prior to the signing of inform consent form.
• In screening period male QTcF interval >450 ms; Female QTcF interval >470 ms (calculated by the Fridericia formula).
• Left ventricular ejection fraction (LVEF) < 50% during the screening period.
• Diagnosis of immunodeficiency, or history or syndrome of active as well as former autoimmune disease with risk of relapse, or a disease requiring systemic steroid hormone or immunosuppressive drug therapy.
• Subjects with a history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS).
• Co-infection HBV and HCV.
• Presence of any active infection requiring systemic therapy.
• Patients who are still on any other investigational medications treatment at the time of screening.
• Previous treatment with cell therapy, tumor vaccines, cytokines, or growth factors for cancer control.
• Patients with prior intolerance to tislelizumab resulting in permanent termination of tislelizumab.
• History or presence of significant lung disease.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Beijing Cancer Hospital — Пекин
• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06541639 · EVM16CX01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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