A Study of AK146D1 for Injection in Advanced Solid Tumors

Официальное название

A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 for Injection, an Anti-Trop2/Nectin4 Bispecific Antibody-drug Conjugate, in Patients With Advanced Solid Tumors

Обзор

This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK146D1 for injection in advanced solid tumors.

Вмешательства

• Препарат AK146D1 for injection
  AK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate

Первичные конечные точки

• Number of participants with dose limiting toxicities (DLTs) [Срок оценки: During the first 3 weeks of treatment.]
• Number of participants with adverse events (AEs) [Срок оценки: From the time of signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.]

Вторичные конечные точки (8)

• Serum PK concentration of AK146D1 [Срок оценки: From pre-dose to the end of the last dose, an average of 6 months.]
• Anti-drug antibodies (ADA) [Срок оценки: From pre-dose to 30 days post end of treatment]
• Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 [Срок оценки: Up to approximately 2 years]
• Disease Control Rate (DCR) assessed 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]
• Time to response (TTR) 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]
• Overall survival (OS) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Be able to understand and voluntarily sign the written informed consent form.
• Aged of ≥ 18 years and ≤75 years.
• ECOG PS 0 or 1.
• The expected lifespan is ≥3 months.
• Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
• At least one measurable lesion according to RECIST v1.1.
• Have sufficient organ function.
• Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception

Критерии исключения

• Having other active malignancies within 3 years.
• Currently participating in another interventional clinical study.
• Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
• Having received any treatment targeting Trop2 or Nectin4.
• Having received systemic anti-tumor treatment within 4 weeks or 1 cycle interval of the regimen or major surgical operations within 4 weeks before the first administration.
• Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 5.0 grade 1 or lower.
• Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks.
• Subjects with active autoimmune diseases requiring systemic treatment within 2 years.
• Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
• Known to be positive for HIV and other infections.
• Previous history of severe hypersensitivity reactions.
• Live attenuated vaccines were received within 4 weeks.
• Subjects with a history of mental illness and incapacitated or limited capacity.
• Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• SunYat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07067567 · AK146D1-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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