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Набира участници Фаза 2 2025-522107-18-00

A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina-S) in Participants with Non-Small Cell Lung Cancer

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Locally advanced or metastatic Non-Small Cell Lung Cancer

Спонсор: Genmab A/S

Налично на: БГ
Обобщение
Trial status: Authorised 1.Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 2.Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 3.Progression-free Survival (PFS) [Time Frame: Approximately 4 years], 4.Overall Survival (OS) [Time Frame: Approximately 4 years], 5.Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes [Time Frame: Approximately 12 months], 6.Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes[Time Frame: Approximately 12 months], 7.Number of Participants with Antidrug Antibodies (ADAs) [Time Frame: Approximately 12 months], 8.Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Approximately 4 years] Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [Time Frame: Approximately 3 years]
Описание
1.Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 2.Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 3.Progression-free Survival (PFS) [Time Frame: Approximately 4 years], 4.Overall Survival (OS) [Time Frame: Approximately 4 years], 5.Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes [Time Frame: Approximately 12 months], 6.Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes[Time Frame: Approximately 12 months], 7.Number of Participants with Antidrug Antibodies (ADAs) [Time Frame: Approximately 12 months], 8.Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Approximately 4 years]
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 107 participants
Интервенции
PEGFILGRASTIM
Drug
Rinatabart Sesutecan
Drug
Места на провеждане 8
Белгия (1)
Франция (1)
Германия (1)
Унгария (1)
Италия (1)
Нидерландия (1)
Полша (1)
Испания (1)
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
14.04.2026
Регистрационен номер
2025-522107-18-00
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

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