A Phase I Study of JSKN021 in Advanced Solid Tumors

Официальное название

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors

Обзор

This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.

Вмешательства

• Препарат JSKN021
  JSKN021 administered intravenously at selected dose levels according to protocol

Первичные конечные точки

• Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN021) [Срок оценки: From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.]
• Dose-limiting toxicity (DLT) [Срок оценки: 21 days from the first dose]
• Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021. [Срок оценки: Up to 24 months]

Вторичные конечные точки (12)

• Objective response rate (ORR) [Срок оценки: Up to 24months]
• Duration of response (DoR) [Срок оценки: Up to 24months]
• Disease control rate (DCR) [Срок оценки: Up to 24months]
• Progression-Free Survival (PFS) [Срок оценки: Up to 24months]
• Overall survival(OS) [Срок оценки: Up to 24months]
• Immunogenicity [Срок оценки: Up to 24months]
• Maximum concentration (Cmax) of JSKN021 [Срок оценки: Up to 24months]
• Time to maximum concentration (Tmax) of JSKN021 [Срок оценки: Up to 24 months.]
• Trough concentration (Ctrough) of JSKN021 [Срок оценки: Up to 24 months]
• Area under the concentration-time curve of JSKN021 [Срок оценки: Up to 24 months]
• Volume of distribution (V) of JSKN021 [Срок оценки: Up to 24 months]
• Elimination half-life (t1/2) of JSKN021 [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

• Voluntarily participate and sign the informed consent form.
• Age ≥ 18 and ≤ 75 years old, male or female.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
• Expected survival ≥ 3 months.
• Histologically or cytologically confirmed malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.
• At least one measurable lesion at baseline according to RECIST 1.1 criteria.
• Adequate organ function.
• Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
• Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
• Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
• Adequate washout period of previous therapy before the first dose.

Критерии исключения

• Complicated with other malignant tumors within 3 years before the first dose.
• History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
• Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.
• Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
• Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
• Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
• Uncontrolled infection.
• Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
• Toxicity of previous anti-tumor treatment has not fully or partially recovered.
• Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
• Pregnant and/or lactating women, or planning to become pregnant during the study period.
• Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• Tumor Hospital of Guangxi Medical University — Nanning
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
• Jiangsu Province Hospital — Нанкин
• Xuzhou Central Hospital — Xuzhou
• Affiliated Hospital of Jining Medical College — Jining
• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07617727 · JSKN021-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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