A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.

Официальное название

A Multicenter, Open-label, Phase Ib/II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 Combined With Toripalimab, With or Without Cisplatin, in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma.

Обзор

This is a multicenter, open-label, Phase Ib/II study conducted in China to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of YL201 combined with Toripalimab (doublet regimen) or YL201 combined with Toripalimab and Cisplatin (triplet regimen) in subjects with recurrent or metastatic nasopharyngeal carcinoma.

Вмешательства

• Препарат YL201
  YL201 will be administered as an IV infusion
• Препарат Toripalimab
  Toripalimab will be administered as an IV infusion
• Препарат Cisplatin
  Cisplatin will be administered as an IV infusion

Первичные конечные точки

• Number of Participants Experiencing Dose-limiting toxicities (DLTs) [Срок оценки: Approximately within 36 months]
• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Approximately within 36 months]
• Progression-Free Survival (PFS) as assessed by RECIST v1.1 [Срок оценки: Approximately within 36 months]

Вторичные конечные точки (10)

• Objective Response Rate (ORR) [Срок оценки: Approximately within 36 months]
• Disease Control Rate (DCR) [Срок оценки: Approximately within 36 months]
• Time to Response (TTR) [Срок оценки: Approximately within 36 months]
• Duration of Response (DoR) [Срок оценки: Approximately within 36 months]
• Overall survival(OS) [Срок оценки: Approximately within 36 months]
• Incidence of anti-drug antibodies (ADA) to YL201 (and to Toripalimab, if necessary) [Срок оценки: Approximately within 36 months]
• Characterize the PK parameter AUC of YL201 and its metabolites, if applicable [Срок оценки: Approximately within 36 months]
• Characterize the PK parameter Cmax of YL201 and its metabolites, if applicable [Срок оценки: Approximately within 36 months]
• Characterize the PK parameter Ctrough of YL201 and its metabolites, if applicable [Срок оценки: Approximately within 36 months]
• Characterize the PK parameter t1/2 of YL201 and its metabolites, if applicable [Срок оценки: Approximately within 36 months]

Критерии участия

Критерии включения

• Voluntarily sign a written informed consent form (ICF).
• Aged ≥18 years and ≤75 years, male or female.
• ECOG performance status score of 0 or 1.
• Life expectancy ≥ 3 months.
• Disease and treatment history:

• Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma that is not amenable to curative treatment.
• Patients with newly diagnosed advanced nasopharyngeal carcinoma, categorized as Stage IV according to the 9th Edition of the American Joint Committee on Cancer (AJCC) Staging System; or those with recurrent nasopharyngeal carcinoma deemed unsuitable for local treatment
• Metastatic or recurrent patients who are systemic treatment naïve.
• At least one measurable lesion according to RECIST v1.1.
• Adequate organ function.

Критерии исключения

• History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects who have been cured of other tumors by local therapy, such as basal cell carcinoma, squamous cell carcinoma of skin, bladder cancer in situ, cervical carcinoma in situ, or breast cancer in situ, are not excluded.
• Patients with brainstem metastases, leptomeningeal metastases, spinal cord metastases, or spinal cord compression.
• Patients with severe, uncontrolled cardiovascular disease.
• Patients with concomitant pulmonary disease resulting in clinically severe impairment of respiratory function.
• History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring corticosteroid therapy, OR current ILD or non-infectious pneumonitis.
• Prior treatment with a B7-H3 targeted therapy (including antibodies, antibody-drug conjugates \[ADCs\], CAR-T cells, and other agents), or with a topoisomerase I inhibitor or an ADC containing a topoisomerase I inhibitor payload.
• Prior treatment with a PD-(L)1 inhibitor (including antibodies, antibody-drug conjugates \[ADCs\], CAR-T cells, and other agents).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 20 центров

• Chongqing University Cancer Hospital — Чунцин
• Fujian Cancer Hospital — Фучжоу
• The First Affiliated Hospital of Xiamen University — Xiamen
• Zhangzhou Municiple Hospital of Fujian Province — Zhangzhou
• Dongguan People's Hospital — Дунгуань
• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Гуанчжоу
• Sun Yat-sen University Cancer Center — Гуанчжоу
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Гуанчжоу
• … и ещё 12 центров

Идентификаторы

NCT: NCT07258979 · YL201-CN-105-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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