RecruitingPhase 1Phase 2NCT06637423

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

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)


Sponsor

Merck Sharp & Dohme LLC

Enrollment

32 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests sacituzumab tirumotecan (MK-2870), an antibody-drug combination, as a treatment delivered directly into the bladder (intravesical) for people with recurrent low-grade, non-muscle-invasive bladder cancer (cancer confined to the inner lining of the bladder). **You may be eligible if...** - You have been diagnosed with recurrent low-grade bladder cancer (Ta stage) that remains in the bladder lining - Your tumor is visible on a recent bladder scope (within the past 12 weeks) - You have had multiple tumors, early recurrence, a large solitary tumor (>3 cm), or previous bladder treatments that did not work - You are in reasonable health (ECOG 0–2) **You may NOT be eligible if...** - You have a newly diagnosed (first-ever) low-grade bladder cancer - You have ever had high-grade bladder cancer or cancer that has invaded the muscle wall - You have conditions preventing normal urination or holding urine - You have active inflammatory bowel disease or uncontrolled heart or brain vascular disease - You have severe dry eye syndrome or chronic corneal disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab tirumotecan

Intravesical administration

DRUGRescue 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, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.

DRUGSupportive 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.


Locations(13)

Michael G Oefelein Clinical Trials ( Site 0053)

Bakersfield, California, United States

Moffitt Cancer Center ( Site 0057)

Tampa, Florida, United States

Northwestern University ( Site 0051)

Chicago, Illinois, United States

Johns Hopkins University ( Site 0055)

Baltimore, Maryland, United States

Princess Margaret Cancer Centre ( Site 0003)

Toronto, Ontario, Canada

CIUSSS de l'Estrie-CHUS ( Site 0002)

Sherbrooke, Quebec, Canada

Hôpital Claude Huriez ( Site 0012)

Lille, Nord, France

HENRI MONDOR HOSPITAL ( Site 0011)

Créteil, Val-de-Marne, France

Gustave Roussy ( Site 0013)

Villejuif, Val-de-Marne, France

Erasmus Medisch Centrum ( Site 0032)

Rotterdam, South Holland, Netherlands

Hospital Universitario Virgen de la Victoria ( Site 0043)

Málaga, Andalusia, Spain

Hospital Universitario 12 de Octubre ( Site 0042)

Madrid, Spain

St Bartholomew s Hospital ( Site 0061)

London, London, City of, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06637423


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