JSKN033 in Chinese Subjects with Advanced Malignant Tumors

Официальное название

Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN033 in Chinese Subjects with Advanced Malignant Tumors

Обзор

This is a phase I/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors.

Вмешательства

• Препарат JSKN033
  JSKN033 should be administered subcutaneously on the first day of each week cycle/ each 2-week cycle

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: Up to 12 months]
• Maximum Tolerated Dose (MTD) or recommend Phase II dose (RP2D). [Срок оценки: Up to 12 months]
• Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAE) and Treatment Related Adverse Events (TRAE) [Срок оценки: Throughout the duration of the study, approximately 2 years]

Вторичные конечные точки (7)

• Anti-drug antibodies (ADA) and neutralizing antibodies [Срок оценки: Throughout the duration of the study, about 2 years]
• Objective response rate (ORR) [Срок оценки: Throughout the duration of the study, about 2 years]
• Disease control rate (DCR) [Срок оценки: Throughout the duration of the study, about 2 years]
• Progression-free survival (PFS) [Срок оценки: Throughout the duration of the study, about 2 years]
• Maximum concentration (Cmax) [Срок оценки: Throughout the duration of the study, about 2 years]
• Time at which Cmax is reached (Tmax) [Срок оценки: Throughout the duration of the study, about 2 years]
• Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast) [Срок оценки: Throughout the duration of the study, about 2 years]

Критерии участия

Критерии включения

• Be able to understand informed consent form, voluntarily participate and sign informed consent form.
• Age ≥18 year (at the time consent is obtained), male or female.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Has a Life expectancy ≥3 months.
• Has a pathologically documented advanced/unresectable or metastatic solid malignant tumor that is refractory to or intolerable with standard treatment.
• Has at least 1 measurable lesion at baseline according to RECIST 1.1 criteria.
• Must have adequate organ function prior to the start of JSKN033.
• Negative urine/serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.

Критерии исключения

• Has clinically active brain metastases.
• Previously received any other investigational drug within 28 days prior to enrollment.
• Previously received local palliative treatment within 14 days prior to enrollment.
• Previously received major surgeries within 28 days prior to enrollment.
• Need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment.
• Previously received live vaccine within 28 days prior to enrollment.
• Previously received antibody conjugate drug with topoisomerase I inhibitor.
• Has a history of other primary malignant tumors within 5 years prior to enrollment.
• Has uncontrolled comorbidities as specified by the protocol.
• Has a history of interstitial pneumonia/lung disease requiring systemic hormonal therapy, or suspected interstitial pneumonia/lung disease that cannot be ruled out by imaging during screening period.
• Subjects with uncontrolled large serous cavity effusion or moderate to large serous cavity effusion requiring repeated drainage (recurrent within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, etc.
• Toxicities of previous antitumor therapy did not resolve to grade 1 defined by CTCAE v5.0.
• Has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient to the study drug.
• Has a history of allogeneic bone marrow or organ transplantation.
• Pregnant or breastfeeding female patients.
• Other conditions that the investigator considers unsuitable to participate in this clinical trial, including but not limited to psychiatric disorders, alcoholism or drug abuse, etc.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06770881 · JSKN033-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗