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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514983-23-00 | Registry Identifier | EU CT | |
| U1111-1308-6998 | Registry Identifier | UTN | |
| MK-2870-027 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab tirumotecan | Experimental | Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab tirumotecan | Drug | Intravesical administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to approximately 10 weeks |
| 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. | Up to approximately 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to approximately 6 weeks |
| Maximum Serum Concentration (Cmax) of sac-TMT ADC |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael G Oefelein Clinical Trials ( Site 0053) | Recruiting | Bakersfield | California | 93301 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| 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. |
|
Blood samples will be collected to determine the Cmax of sac-TMT ADC |
| Up to approximately 6 weeks |
| Minimum Serum Concentration (Cmin) of sac-TMT ADC | Blood samples will be collected to determine the Cmin of sac-TMT ADC | Up to approximately 6 weeks |
| Serum Apparent terminal half-life (t½) of sac-TMT ADC | Blood samples will be collected to determine the t1/2 of sac-TMT ADC | Up to approximately 6 weeks |
| Serum AUC of sac-TMT Total Antibody (TAb) | Blood samples will be collected to determine the AUC of sac-TMT Tab | Up to approximately 6 weeks |
| Serum Cmax of sac-TMT Tab | Blood samples will be collected to determine the Cmax of sac-TMT Tab | Up to approximately 6 weeks |
| Serum Cmin of sac-TMT Tab | Blood samples will be collected to determine the Cmin of sac-TMT Tab | Up to approximately 6 weeks |
| Serum t½ of sac-TMT Tab | Blood samples will be collected to determine the t1/2 of sac-TMT Tab | Up to approximately 6 weeks |
| Plasma AUC of sac-TMT payload | Blood samples will be collected to determine the AUC of sac-TMT payload | Up to approximately 6 weeks |
| Plasma Cmax of sac-TMT payload | Blood samples will be collected to determine the Cmax of sac-TMT payload | Up to approximately 6 weeks |
| Plasma Cmin of sac-TMT payload | Blood samples will be collected to determine the Cmin of sac-TMT payload | Up to approximately 6 weeks |
| Plasma t½ of sac-TMT payload | Blood samples will be collected to determine the t1/2 of sac-TMT payload | Up to approximately 6 weeks |
| Complete Response Rate (CRR) | CRR is defined as the percentage of participants who will be absent of residual tumor in the bladder assessed locally by cystoscopy evaluation and negative urine cytology and/or biopsy and imaging if applicable. | Up to approximately 6 months |
| Duration of Complete Response (DCR) | Duration of CR for participants who demonstrate CR is defined as the time from the first documented evidence of CR (absence of residual tumor in the bladder assessed locally by cystoscopy evaluation and negative urine cytology and/or biopsy and imaging if applicable) until the occurrence of histologically confirmed nonmuscle invasive urothelial carcinoma (UC) by local pathology review or locally advanced or metastatic UC, or death due to any cause, whichever occurs first. | Up to approximately 24 months |
| Moffitt Cancer Center ( Site 0057) | Recruiting | Tampa | Florida | 33612 | United States |
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| Northwestern University ( Site 0051) | Recruiting | Chicago | Illinois | 60611 | United States |
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| Johns Hopkins University ( Site 0055) | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Princess Margaret Cancer Centre ( Site 0003) | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002) | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| Hôpital Claude Huriez ( Site 0012) | Active, not recruiting | Lille | Nord | 59037 | France |
| HENRI MONDOR HOSPITAL ( Site 0011) | Active, not recruiting | Créteil | Val-de-Marne | 94010 | France |
| Gustave Roussy ( Site 0013) | Active, not recruiting | Villejuif | Val-de-Marne | 94805 | France |
| Erasmus Medisch Centrum ( Site 0032) | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
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| Hospital Universitario Virgen de la Victoria ( Site 0043) | Recruiting | Málaga | Andalusia | 29010 | Spain |
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| Hospital Universitario 12 de Octubre ( Site 0042) | Recruiting | Madrid | 28041 | Spain |
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| St Bartholomew s Hospital ( Site 0061) | Recruiting | London | London, City of | EC1A 7BE | United Kingdom |
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| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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