A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)

Официальное название

A Phase 1/2 Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravesical Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (NMIBC)

Обзор

The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.

Вмешательства

• Препарат Sacituzumab tirumotecan
  Intravesical administration
• Препарат Rescue medication
  Participants are allowed to take rescue medication for stomatitis or oral mucositis. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion or steroid mouthwash (dexamethasone or equivalent), antiemetic medications, oral nystatin suspension or antifungal medications, antidiarrheal agents, an
• Препарат Supportive care measures
  Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Artificial tear drops or gel may be given as a supportive care for Ocular Surface Toxicity.

Первичные конечные точки

• Number of Participants with Dose Limiting Toxicity (DLT) [Срок оценки: Up to approximately 7 weeks]
• Number of Participants Experiencing an Adverse Event (AE) [Срок оценки: Up to approximately 10 weeks]
• Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE) [Срок оценки: Up to approximately 6 weeks]

Вторичные конечные точки (12)

• Area Under the Serum Concentration-Time Curve (AUC) of sacituzumab tirumotecan (sac-TMT) Antibody-Drug Conjugate (ADC) [Срок оценки: Up to approximately 6 weeks]
• Maximum Serum Concentration (Cmax) of sac-TMT ADC [Срок оценки: Up to approximately 6 weeks]
• Minimum Serum Concentration (Cmin) of sac-TMT ADC [Срок оценки: Up to approximately 6 weeks]
• Serum Apparent terminal half-life (t½) of sac-TMT ADC [Срок оценки: Up to approximately 6 weeks]
• Serum AUC of sac-TMT Total Antibody (TAb) [Срок оценки: Up to approximately 6 weeks]
• Serum Cmax of sac-TMT Tab [Срок оценки: Up to approximately 6 weeks]
• Serum Cmin of sac-TMT Tab [Срок оценки: Up to approximately 6 weeks]
• Serum t½ of sac-TMT Tab [Срок оценки: Up to approximately 6 weeks]
• Plasma AUC of sac-TMT payload [Срок оценки: Up to approximately 6 weeks]
• Plasma Cmax of sac-TMT payload [Срок оценки: Up to approximately 6 weeks]
• Plasma Cmin of sac-TMT payload [Срок оценки: Up to approximately 6 weeks]
• Plasma t½ of sac-TMT payload [Срок оценки: Up to approximately 6 weeks]

Критерии участия

Критерии включения

The key inclusion criteria include but are not limited to the following:

• Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder
• Must have visible tumor by cystoscopy within 12 weeks prior to first dose
• Has intermediate-risk NMIBC defined as 1 or more of the following risk factors:

• Multiple tumors
• >1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening
• Early recurrence (<1 year) of the initial diagnosis of low-grade disease
• Solitary tumor >3 cm
• Failure of prior intravesical treatment
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose

Критерии исключения

The key exclusion criteria include but are not limited to the following:

• Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder
• Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
• Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)
• Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and/or blepharitis, or severe corneal disease that prevents and/or delays corneal healing
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease, ulcerative colitis, or chronic diarrhea)
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Known additional malignancy that is progressing or has required active treatment within the past 3 years
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

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

США · 4 центра

• Michael G Oefelein Clinical Trials ( Site 0053) — Bakersfield
• Moffitt Cancer Center ( Site 0057) — Tampa
• Northwestern University ( Site 0051) — Chicago
• Johns Hopkins University ( Site 0055) — Baltimore

Франция · 3 центра

• Hôpital Claude Huriez ( Site 0012) — Lille
• HENRI MONDOR HOSPITAL ( Site 0011) — Créteil
• Gustave Roussy ( Site 0013) — Villejuif

Канада · 2 центра

• Princess Margaret Cancer Centre ( Site 0003) — Toronto
• Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospital — Sherbrooke

Испания · 2 центра

• Hospital Universitario Virgen de la Victoria ( Site 0043) — Málaga
• Hospital Universitario 12 de Octubre ( Site 0042) — Madrid

Нидерланды · 1 центр

• Erasmus Medisch Centrum ( Site 0032) — Rotterdam

Великобритания · 1 центр

• St Bartholomew s Hospital ( Site 0061) — London

Идентификаторы

NCT: NCT06637423 · 2870-027 · 2024-514983-23-00 · U1111-1308-6998 · MK-2870-027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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