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

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Non-Muscle Invasive Bladder Cancer

Treatments

Drug: Sacituzumab tirumotecan

Drug: Supportive care measures

Drug: Rescue medication

Study type

Interventional

Funder types

Industry

Identifiers

NCT06637423

MK-2870-027 (Other Identifier)

U1111-1308-6998 (Other Identifier)

2870-027

2024-514983-23-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.