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

Part of paid clinical trials in Bakersfield, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06637423
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab tirumotecan — DRUG
    Intravesical administration
  • Rescue medication — DRUG
    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, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.
  • Supportive care measures — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 20, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jul 31, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab tirumotecan
    Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Up to approximately 7 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Michael G Oefelein Clinical Trials ( Site 0053)BakersfieldCalifornia93301
Study Coordinator
661-310-1063
Moffitt Cancer Center ( Site 0057)TampaFlorida33612
Study Coordinator
888-663-3488
Northwestern University ( Site 0051)ChicagoIllinois60611
Study Coordinator
312-695-1102
Johns Hopkins University ( Site 0055)BaltimoreMaryland21287
Study Coordinator
410-614-0009

Find similar trials in Bakersfield, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Michael G Oefelein Clinical Trials· Bakersfield, CAMoffitt Cancer Center· Tampa, FLNorthwestern University· Chicago, ILJohns Hopkins University· Baltimore, MD

Related Studies