Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 1/Phase 2
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
décembre 2024
juillet 2028
04 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Study Coordinator | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Study Coordinator | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Claude Huriez ( Site 0012) - 59037 - Lille - Nord - France | Study Coordinator | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
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
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
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.