AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant Tumors

Официальное название

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant Tumors

Обзор

A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of AK137 in patients with advanced malignant tumors.

Вмешательства

• Препарат AK137
  IV infusion, specified dose on specified days.

Первичные конечные точки

• AEs [Срок оценки: From time ICF is signed until 90 days after last dose of AK137]
• DLT [Срок оценки: During the first 28-day of treatment with AK137]

Вторичные конечные точки (9)

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 2 years]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years]
• Duration of Response (DoR) [Срок оценки: Up to approximately 2 years]
• Time to response (TTR) [Срок оценки: Up to approximately 2 years]
• Progression Free Survival (PFS) [Срок оценки: Up to approximately 2 years]
• Overall Survival (OS) [Срок оценки: Up to approximately 2 years]
• Cmax of AK137 [Срок оценки: From first dose of study drug through end of treatment (up to approximately 2 years)]
• Cmin of AK137 [Срок оценки: From first dose of study drug through end of treatment (up to approximately 2 years)]
• Number of subjects who develop detectable anti-drug antibodies (ADAs) [Срок оценки: From first dose of study drug through 30 days after last dose of study drug]

Критерии участия

Критерии включения

• Written and signed informed consent.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
• Life expectancy ≥3 months.
• Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
• Subject must have at least one measurable lesion according to RECIST Version1.1.
• Adequate organ function.

Критерии исключения

• Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.
• Receipt of any anti-CD73, anti-LAG-3 treatment.
• Experienced a toxicity that led to the permanent discontinuation of prior immunotherapy. All adverse events (AEs) while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening. Additionally, the use of immunosuppression other than corticosteroids was required.
• Unresolved toxicities from prior anticancer therapy, defined as not having resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels specified in the inclusion/exclusion criteria, except for toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
• Major surgical procedure within 4 weeks prior to the first dose of AK137 or still recovering from prior surgery.
• History of organ transplant.
• Known allergy or reaction to any component of the AK137 formulation. History of severe hypersensitivity reactions to other mAbs.

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

• Shanghai Pulmonary Hospital — Шанхай

Идентификаторы

NCT: NCT06691360 · AK137-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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