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.
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
Multiple tumors
>1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening
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
Single group
Sacituzumab tirumotecan
DrugIntravesical administration
Rescue medication
DrugParticipants 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
DrugParticipants 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.
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.
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.
Number of Participants Discontinuing Study Treatment due to 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 discontinue study treatment due to an AE will be reported.
Area Under the Serum Concentration-Time Curve (AUC) of sacituzumab tirumotecan (sac-TMT) Antibody-Drug Conjugate (ADC)
Blood samples will be collected to determine the AUC of sac-TIMT ADC
Maximum Serum Concentration (Cmax) of sac-TMT ADC
Blood samples will be collected to determine the Cmax of sac-TMT ADC
Minimum Serum Concentration (Cmin) of sac-TMT ADC
Blood samples will be collected to determine the Cmin of sac-TMT ADC
Serum Apparent terminal half-life (t½) of sac-TMT ADC
Blood samples will be collected to determine the t1/2 of sac-TMT ADC
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