A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer

Официальное название

A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Breast Cancer

Обзор

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced breast cancer. Participants will receive study treatment with AK138D1 alone or in combination with ivonescimab, undergo safety assessments and tumor evaluations, and be followed for treatment tolerability, antitumor activity, and clinical outcomes.

Подробное описание

This is a multicenter, open-label Phase Ib/II study of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced breast cancer. The Phase Ib portion is designed to evaluate the safety, tolerability, and preliminary antitumor activity of AK138D1 in combination with ivonescimab. The Phase II portion is designed to evaluate the safety and efficacy of AK138D1 as monotherapy or in combination with ivonescimab.

Вмешательства

• Препарат AK138D1
  Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.
• Препарат Ivonescimab
  Enrolled subjects will receive intravenous infusion (IV) of ivonescimab according to the dosing regimen specified in their cohort.
• Препарат treatment of physician's choice
  Enrolled subjects will receive treatment of physician's choice according to one of the protocol-specified regimens selected by the investigator, based on the investigator's decision.

Первичные конечные точки

• Adverse events (AEs) [Срок оценки: Up to approximately 2 years]
• Overall Response Rate (ORR) assessed by investigator per RECIST v1.1 [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (8)

• Peak Plasma Concentration (Cmax) [Срок оценки: Up to approximately 2 years]
• Area under the plasma concentration versus time curve (AUC) [Срок оценки: Up to approximately 2 years]
• Anti-drug antibodies (ADA) [Срок оценки: Up to approximately 2 years]
• Disease Control Rate (DCR) assessed by investigator per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
• Duration of response (DoR) assessed by the investigator per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
• Progression Free Survival (PFS) assessed by investigator per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
• Time to response (TTR) assessed by the investigator per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
• Overall Survival (OS) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• The subject must sign the written informed consent form (ICF) voluntarily;
• At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
• ECOG performance status score of 0 or 1;
• Has a life expectancy of ≥ 3 months;
• At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.
• Adequate organ function.

Критерии исключения

• Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
• Presence of active central nervous system (CNS) metastases.
• Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
• Untreated subjects with active hepatitis B or active hepatitis C;
• Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
• Known active syphilis infection;
• Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
• Other reasons for ineligibility as evaluated by the investigator.

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 · 3 центра

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Harbin Medical University Cancer Hospital — Харбин
• West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT07560124 · AK138D1-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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