A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

Официальное название

A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 in Patients With Selected Advanced Solid Tumors

Обзор

The study is a dose-escalation and dose-expansion study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent or in combination with standard of care (SOC) in patients with selected types of advanced solid tumors.

Подробное описание

Monotherapy:

A dose-escalation (Part A) and expansion (Part B) study of ASKG915 monotherapy was initiated to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with advanced solid tumors.

Combination therapy:

A dose-optimization (Part C) srudy of ASKG915 in combination with standard of care (SOC) in patients was conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in patients with selected types of advanced solid tumors.

Вмешательства

• Биопрепарат ASKG915
  ASKG915 is administered intravenously at a scheduled dose. The drug was given once every 3 weeks or 4 weeks for a cycle.
• Препарат Paclitaxel + Bevacizumab
  Paclitaxel is administered intravenously at a dose of 80 mg/m², once weekly on a 21-day cycle. Bevacizumab is administered intravenously at dose of 15mg/kg, once every 3 weeks on a 21-day cycle.
• Препарат Fruquintinib
  The recommended dose of Fruquintinib is 5 mg orally once daily, with or without food for the first 21 days of each 28-day cycle.
• Препарат Docetaxel
  Docetaxel is administered intravenously at 75 mg/m², once every 3 weeks on a 21-day cycle.

Первичные конечные точки

• Dose limiting toxicities (DLTs) [Срок оценки: 21days or 28 days]
• Adverse events(AEs) [Срок оценки: From the first dose to 30 days after the last dose]

Вторичные конечные точки (7)

• Maximum plasma concentration (Cmax) [Срок оценки: Until treatment discontinuation or for a maximum of 2 years]
• Area under the concentration time curve (AUC) [Срок оценки: Until treatment discontinuation or for a maximum of 2 years]
• Plasma clearance rate (CL) [Срок оценки: Until treatment discontinuation or for a maximum of 2 years]
• Evaluation of immunogenicity [Срок оценки: Until treatment discontinuation or for a maximum of 2 years]
• Objective Response Rate (ORR) [Срок оценки: Until disease progression or for a maximum of 2 years]
• Duration of response (DOR) [Срок оценки: Until disease progression or for a maximum of 2 years]
• Progression-free survival (PFS) [Срок оценки: Until disease progression or for a maximum of 2 years]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
• ECOG performance status of ≤ 2.
• Life expectancy of ≥ 3 months.
• The results of the laboratory tests must meet all criteria.

Критерии исключения

• Patients have received antitumor therapy during the first 4 weeks before study drug use.
• Received a live attenuated vaccine within 4 weeks prior to C1D1.
• Known cerebral parenchymal metastasis or meningeal metastasis.
• History of serious cardiovascular or cerebrovascular diseases.
• Active or recurrent autoimmune diseases.
• History of ascites or pleural effusion requiring drainage.
• Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Columbia University Irving Medical Center — New York
• UPMC Hillman Cancer Center — Pittsburgh

Китай · 2 центра

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

Идентификаторы

NCT: NCT05867420 · ASKG915-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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