SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors

Официальное название

A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors

Обзор

This study is a Phase Ib/II clinical study. It includes two stages: Phase Ib and Phase II. In the Phase Ib stage, the primary objective is to evaluate the safety and tolerability of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors, and to provide a basis for dose selection in later clinical studies. The primary objective of the Phase II stage is to assess efficacy and safety of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors.

Вмешательства

• Биопрепарат SYS6006
  Drug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection
• Биопрепарат Enlonstobart
  Enlonstobart IV

Первичные конечные точки

• Phase Ib: Incidence and frequency of dose-limiting toxicities (DLTs) during the study (applicable to the combination therapy dose-escalation phase) [Срок оценки: Within 21 days after the start of the treatment]
• Phase Ib: Incidence and frequency of treatment-emergent adverse events (TEAEs) . [Срок оценки: Through study completion, an average of l year]
• Phase Ib:Incidence and frequency of serious adverse events (SAEs) [Срок оценки: Through study completion, an average of l year]
• Phase Ib:Maximum tolerated dose (MTD) [Срок оценки: Every 21 days while on treatment (estimated 6 months)]
• Phase Ib: Recommended Phase II dose (RP2D) [Срок оценки: Every 21 days while on treatment (estimated 6 months)]
• Phase II: ORR as assessed by the investigator according to RECIST v1.1 [Срок оценки: through study completion, an average of 1year.]
• Phase II: Incidence and frequency of TEAEs. [Срок оценки: through study completion, an average of l year]
• Phase II:Incidence and frequency of SAEs. [Срок оценки: through study completion, an average of l year]

Вторичные конечные точки (9)

• Disease control rate (DCR) per RECIST 1.1 [Срок оценки: Up to approximately 24 months after the first participant is enrolled]
• Duration of response (DoR) per RECIST 1.1 [Срок оценки: Up to approximately 24 months after the first participant is enrolled]
• Progression free survival (PFS) per RECIST 1.1 [Срок оценки: Up to approximately 24months after the first participant is enrolled]
• Time to response(TTR) [Срок оценки: Up to approximately 24months after the first participant is enrolled]
• Overall survival(OS) [Срок оценки: Up to approximately 24 months after the first participant is enrolled]
• Frequency and severity of adverse events (AEs) (NCI CTCAE 5.0) [Срок оценки: Up to approximately 24 months after the first participant is enrolled]
• PK parameters: The plasma concentration of enlonstobart [Срок оценки: Up to approximately 24 months after the first participant is enrolled]
• Correlation between PD-L1 expression level (measured as Tumor Proportion Score [TPS] by 22C3 IHC assay) and objective response rate (ORR, as assessed by RECIST 1.1 criteria) [Срок оценки: Up to approximately 24 months after the first participant is enrolled]
• To evaluate changes in cytokines such as interferon-alpha (IFNα) and the activation status of peripheral blood immune cells [Срок оценки: through study completion, an average of l year]

Критерии участия

Критерии включения

• 1\. Able to understand and voluntarily sign the written informed consent form (ICF);
• 2\. Male or female subjects aged over 18 years old (inclusive).
• 3\. Patients with solid tumor who have unresectable locally advanced or metastatic disease;
• 4\. At least one measurable lesion, as defined by RECIST 1.1 criteria;
• 5\. ECOG performance status of 0-2;
• 6\. Expected survival ≥ 3 months;
• 7\. Adequate function of major organs and bone marrow;
• 8\. Women or man of childbearing potential must use highly effective contraception.

Критерии исключения

• 1\. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
• 2\. Patients with a history of autoimmune diseases;
• 3\. Presence of active infection (e.g., subjects are receiving anti-infection therapy);
• 4\. Severe or uncontrolled cardiovascular disorder requiring treatment;
• 5\. Women who are pregnant or breastfeeding.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07622225 · SYS6006-009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗