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

Phase 2RecruitingNCT06637423

Merck Sharp & Dohme LLC32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Muscle Invasive Bladder Cancer

Interventions

Sacituzumab tirumotecanDRUG

Intravesical administration

Rescue medicationDRUG

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 measuresDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (13)

Michael G Oefelein Clinical Trials ( Site 0053)

Bakersfield, California, United States

RECRUITING

Moffitt Cancer Center ( Site 0057)

Tampa, Florida, United States

Outcomes

Primary Outcomes

Number of Participants with Dose Limiting Toxicity (DLT)

DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (7 weeks). All toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0.

Time frame: Up to approximately 7 weeks

Number of Participants Experiencing an Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who experience an AE will be reported.

Time frame: Up to approximately 10 weeks

Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)

Time frame: Up to approximately 6 weeks

Secondary Outcomes

Area Under the Serum Concentration-Time Curve (AUC) of sacituzumab tirumotecan (sac-TMT) Antibody-Drug Conjugate (ADC)

Central Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

Data from ClinicalTrials.gov

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