A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial Carcinoma

Официальное название

An Open Label, Randomized, Multicenter, Phase III Study of SHR-A2102 in Combination With Adebrelimab Versus Gemcitabine in Combination With Cisplatin/Carboplatin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (NEC-UC2)

Обзор

The study is being conducted to evaluate the efficacy of SHR-A2102 with adebrelimab versus gemcitabine in combination with cisplatin/carboplatin in previously untreated locally advanced or metastatic urothelial carcinoma.

Вмешательства

• Препарат SHR-A2102 and Adebrelimab
  SHR-A2102 and Adebrelimab injection
• Препарат Gemcitabine and cisplatin / carboplatin
  Gemcitabine injection and cisplatin injection / carboplatin injection

Первичные конечные точки

• Progression-free survival(PFS), assessed by BICR [Срок оценки: up to 50 months]

Вторичные конечные точки (11)

• Determine the dose of SHR-A2102 in the second phase, participants included in the dose selection analysis were followed up at 6 months in the last case [Срок оценки: Determine the dose of SHR-A2102 in the second phase, participants included in the dose selection analysis were followed up at 6 months in the last case]
• Overall Survival(OS) [Срок оценки: up to 50 months]
• Objective response rate(ORR), assessed by BICR [Срок оценки: up to 50 months]
• Disease control rate(DCR), assessed by BICR [Срок оценки: up to 50 months]
• Duration of response(DoR), assessed by BICR [Срок оценки: up to 50 months]
• PFS, assessed by investigator [Срок оценки: up to 50 months]
• ORR, assessed by investigator [Срок оценки: up to 50 months]
• DCR, assessed by investigator [Срок оценки: up to 50 months]
• DoR, assessed by investigator [Срок оценки: up to 50 months]
• Adverse event(AE) [Срок оценки: up to 50 months]
• serious adverse event(SAE) [Срок оценки: up to 50 months]

Критерии участия

Критерии включения

• Be able to sign the informed consent form in writing.
• Female or male, 18 to 80 years of age (both inclusive).
• ECOG performance status of 0 or 1.
• Expected survival of≥ 3 months.
• Histologically confirmed diagnosis of urothelial carcinoma with radiographic or other confirmation of locally advanced unresectable or metastatic disease.
• No prior systemic therapy for locally advanced or metastatic disease.
• Able to provide archived or fresh tumor tissue for Nectin-4 and PD-L1 expression.
• According to RECIST v1.1, there must be at least one measurable lesion;
• Tolerant to cisplatin or carboplatin.
• Adequate organ functions.
• Agree to use medically approved contraceptive measures.

Критерии исключения

• Planned to receive any other anti-tumor therapy during the study.
• Received other investigational products or treatments not yet marketed within 4 weeks.
• Have received systemic anti-tumor treatment within 4 weeks;have received prior anti-tumor Chinese patent medicine treatment within 2 weeks; palliative radiotherapy or local therapy within 2 weeks.
• Previously received therapy with an antibody-drug conjugate that meets any one of the following characteristics: targeting Nectin-4; containing irinotecan or its derivatives and acting as a topoisomerase I inhibitor.
• Prior treatment with immune checkpoint inhibitors.
• Major surgical procedure other than diagnostic or biopsy within 4 weeks, requiring elective surgery during the trial.
• Active autoimmune disease requiring systemic treatment within 2 years.
• Have experienced adverse events caused by previous anti-tumor treatments that have not recovered to grade ≤1 as per NCI-CTCAE v5.0.
• Uncontrolled central nervous system metastases or carcinomatous meningitis.
• Subjects with clinical symptoms or serous cavity effusion requiring puncture drainage.
• Other malignancies within 5 years.
• History of clinically significant pulmonary disease or any such disease suggested by chest imaging at screening.
• Serious infections requiring intravenous antibiotics, antivirals, or antifungals for control.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• History of immunodeficiency, or history of organ transplant.
• Have experienced arteriovenous thrombosis or cardiovascular and cerebrovascular accidents within 6 months.
• Subjects with clinically significant hemorrhage within 3 months.
• Glycosylated hemoglobin (HbA1c) ≥ 8%.
• Have serious cardiovascular and cerebrovascular diseases.
• Allergic reaction to any component of the study treatment.
• Subjects with active pulmonary tuberculosis.
• Have severe dry eye, active keratitis, or corneal ulcer, or other conditions.
• Female Subjects who are pregnant or planning to become pregnant during the study.
• Other conditions unsuitable into the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT07393542 · SHR-A2102-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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