A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.

Официальное название

A Multicenter, Open-label, Uncontrolled Phase I/II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma, and to Evaluate the Tolerability in Pediatric Patients.

Обзор

This is a multicenter, open-label, uncontrolled Phase I/II study to evaluate the efficacy, safety, and pharmacokinetics of ONO-4538HSC in pediatric patients with malignant solid tumors and in patients with epithelioid sarcoma, and to evaluate the tolerability in pediatric patients. The objective of this study is to explore the tolerability, safety, efficacy, and pharmacokinetics of ONO-4538HSC in patients with pediatric malignant solid tumors. The other objective is to exploratively investigate the efficacy and safety of ONO-4538HSC in patients with epithelioid sarcoma.

Вмешательства

• Препарат ONO-4538HSC
  ONO-4538HSC will be administered subcutaneously once every 4 weeks.

Первичные конечные точки

• Adverse events meeting protocol-defined criteria for a DLT [Срок оценки: 28 days]
• Serious adverse events [Срок оценки: UP to 100 days after the last dose]
• Adverse events [Срок оценки: UP to 100 days after the last dose]
• Response rate (central assessment) [Срок оценки: Through study completion, an average of 6 months]

Вторичные конечные точки (11)

• Serum concentration of nivolumab [Срок оценки: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)]
• Response rate (investigator assessment) [Срок оценки: Through study completion, an average of 6 months]
• Progression-free survival (central assessment and investigator assessment) [Срок оценки: Through study completion, an average of 6 months]
• Disease control rate (central assessment and investigator assessment) [Срок оценки: Through study completion, an average of 6 months]
• Duration of response (central assessment and investigator assessment) [Срок оценки: Through study completion, an average of 6 months]
• Time to response (central assessment and investigator assessment) [Срок оценки: Through study completion, an average of 6 months]
• Best overall response (central assessment and investigator assessment) [Срок оценки: Through study completion, an average of 6 months]
• Maximum percent change from baseline in the sum of diameters of target lesions (central assessment and investigator assessment) [Срок оценки: Through study completion, an average of 6 months]
• Changes in tumor markers over time [Срок оценки: Through study completion, an average of 6 months]
• Adverse events [Срок оценки: UP to 100 days after the last dose]
• Serum concentration of nivolumab [Срок оценки: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)]

Критерии участия

Критерии включения

\[Cohort of pediatric malignant solid tumor Tolerability evaluation part\]

• Patients aged ≥ 12 to < 18 years at the time of signing the informed consent form (ICF)
• Patients with radically/curatively unresectable advanced or metastatic solid tumor who are refractory to or intolerant to standard treatment or for which no standard treatment is available.
• Patients with ECOG PS of 0 to 1

\[Cohort of pediatric malignant solid tumor Expansion part\]

• Patients aged ≥ 12 to < 18 years at the time of signing the informed consent form (ICF)
• Patients with unresectable tumors for whom nivolumab intravenous monotherapy is indicated in adults according to the package insert
• Patients who have at least 1 measurable lesion per RECIST guideline
• Patients with ECOG PS of 0 to 2

\[Cohort of Epithelioid Sarcoma\]

• Patients aged ≥ 12 years of age at the time of signing the informed consent form (ICF). However, patients aged ≥ 12 to < 18 years may be enrolled after tolerability is confirmed in the tolerability evaluation part in the cohort of pediatric malignant solid tumor.
• Patients who are refractory to or ineligible to at least 1 regimen of chemotherapy including doxorubicin for unresectable advanced or recurrent epithelioid sarcoma
• Patients who have at least 1 measurable lesion per RECIST guideline
• Patients with ECOG PS of 0 to 2

\[Common\]

• Life expectancy ≥ 3 months at the time of enrollment

Критерии исключения

• Patients with current or previous severe hypersensitivity reactions to antibody products
• Patients with primary central nervous system tumor
• Patients with brain or meningeal metastases. However, patients who are asymptomatic and do not require treatment can be enrolled.
• Patients with multiple cancers
• Patients who have previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or other therapeutic antibodies or pharmacotherapies for regulation of T cells

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

Япония · 3 центра

• Yokohama City University Hospital — Yokohama
• Osaka International Cancer Institute — Osaka
• National Cancer Center Hospital — Chuo-ku

Идентификаторы

NCT: NCT07734116 · ONO-4538HSC-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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