Testing Sacituzumab Tirumotecan for Bladder Cancer
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)
This study is testing a new treatment called Sacituzumab Tirumotecan for people with recurrent low-grade bladder cancer to see how safe it is and what the best dose is.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | Sacituzumab |
| Locations | 13 sites (Bakersfield, California and 12 other locations) |
| Trial ID | NCT06637423 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and tolerability of Sacituzumab Tirumotecan in patients with recurrent low-grade non-muscle invasive bladder cancer. Participants will receive the drug directly in the bladder, and researchers will determine the maximum tolerated dose to inform future studies. The study focuses on patients with specific risk factors associated with their condition, ensuring a targeted approach to treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with recurrent low-grade non-muscle invasive bladder cancer who meet specific risk criteria.
Not a fit: Patients with newly diagnosed low-grade bladder cancer or a history of high-grade bladder cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent low-grade bladder cancer.
How similar studies have performed: Other studies have explored similar treatments for bladder cancer, but the specific use of Sacituzumab Tirumotecan in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Exclusion Criteria: 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.
Where this trial is running
Bakersfield, California and 12 other locations
- Michael G Oefelein Clinical Trials ( Site 0053) — Bakersfield, California, United States (Recruiting)
- Moffitt Cancer Center ( Site 0057) — Tampa, Florida, United States (Recruiting)
- Northwestern University ( Site 0051) — Chicago, Illinois, United States (Recruiting)
- Johns Hopkins University ( Site 0055) — Baltimore, Maryland, United States (Recruiting)
- Princess Margaret Cancer Centre ( Site 0003) — Toronto, Ontario, Canada (Recruiting)
- CIUSSS de l'Estrie-CHUS ( Site 0002) — Sherbrooke, Quebec, Canada (Recruiting)
- Hôpital Claude Huriez ( Site 0012) — Lille, Nord, France (Recruiting)
- HENRI MONDOR HOSPITAL ( Site 0011) — Créteil, Val-de-Marne, France (Recruiting)
- Gustave Roussy ( Site 0013) — Villejuif, Val-de-Marne, France (Recruiting)
- Erasmus Medisch Centrum ( Site 0032) — Rotterdam, South Holland, Netherlands (Recruiting)
- Hospital Universitario Virgen de la Victoria ( Site 0043) — Málaga, Andalusia, Spain (Recruiting)
- Hospital Universitario 12 de Octubre ( Site 0042) — Madrid, Spain (Recruiting)
- St Bartholomew s Hospital ( Site 0061) — London, London, City of, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.