A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma

Официальное название

An Open Label, Multicenter, Phase Ib/Il Study to Evaluate the Safety, Tolerability, and Efficacy of SHR A2102 in Combination With Other Anti-cancer Agents in Patients With Advanced Urothelial Carcinoma

Обзор

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.

Вмешательства

• Препарат SHR-A2102
  SHR-A2102
• Препарат Adebrelimab injection
  Adebrelimab injection
• Препарат SHR-8068 injection
  SHR-8068 injection

Первичные конечные точки

• Phase I: RP2D of SHR-A2102 combined with Adebrelimab and SHR-8068 in patients with advanced urothelial cancer [Срок оценки: Up to approximately 5 years]
• Phase I: Incidence and severity of adverse events [Срок оценки: Up to approximately 5 years]
• Phase II: ORR by investigator assessment [Срок оценки: Up to approximately 5 years]

Вторичные конечные точки (12)

• Phase I: ORR by investigator assessment [Срок оценки: Up to approximately 5 years]
• Phase I: DCR by investigator assessment [Срок оценки: Up to approximately 5 years]
• Phase I: DoR by investigator assessment [Срок оценки: Up to approximately 5 years]
• Phase I: PFS by investigator assessment [Срок оценки: Up to approximately 5 years]
• Phase I: OS by investigator assessment [Срок оценки: Up to approximately 5 years]
• Phase I: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin [Срок оценки: Up to approximately 5 years]
• Phase I: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb) [Срок оценки: Up to approximately 5 years]
• Phase II: DCR by investigator assessment [Срок оценки: Up to approximately 5 years]
• Phase II: DoR by investigator assessment [Срок оценки: Up to approximately 5 years]
• Phase II: PFS by investigator assessment [Срок оценки: Up to approximately 5 years]
• Phase II: OS by investigator assessment [Срок оценки: Up to approximately 5 years]
• Phase II: Incidence and severity of adverse events [Срок оценки: up to 5 years]

Критерии участия

Критерии включения

• Competent to comprehend, sign, and date an informed consent form.
• Male or female subjects must be age 18 or older.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subjects must have histologically documented, unresectable locally advanced or
• Histologically confirmed locally advanced or metastatic urothelial cancer.Phase Ib, subjects must have failed, be intolerant or refused the standard treatment; Phase II, subjects must not have received systemic antitumor therapy for locally advanced unresectable or metastatic urothelial carcinoma.
• An archival tumor tissue sample or a fresh tissue sample should be provided.
• Subjects must have measurable disease according to RECIST (version 1.1).

Критерии исключения

• Subjects with not adequately treated, or uncontrollable , or active CNS metastases.
• Subjects who have previously received TOPO1-based ADCs.
• Subjects who have received anti-cancer treatment within 4 weeks prior the first dose of study treatment.
• Subjects who have received radiotherapy within 14 days , or chest radiotherapy > 30Gy within 6 months prior to the first dose of study drug.
• Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1.
• Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment.
• Subjects who have known or suspected interstitial pneumonitis.
• Phase Ib: Subjects who have had≥ Grade 3 irAEs during the previous treatment with ICIs.
• Subjects who have any active, known or suspected autoimmune diseases.
• Subjects who have moderate or severe ascites with clinical symptoms, or uncontrolled or moderate or above pleural effusion, or pericardial effusion.
• Subjects who have uncontrolled cardiac diseases or cardiac clinical symptoms.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06639347 · SHR-A2102-207

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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