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NCT Number: NCT06637423

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

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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Key information

Conditions

Non-Muscle Invasive Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Margaret Cancer Centre ( Site 0003), Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sacituzumab tirumotecan

Drug

Intravesical administration

Other names: SKB264, sac-TMT, MK-2870

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.

Primary outcomes

  1. Number of Participants with Dose Limiting Toxicity (DLT)

    Time frame: Up to approximately 7 weeks

    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.

  2. Number of Participants Experiencing an Adverse Event (AE)

    Time frame: Up to approximately 10 weeks

    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.

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

    Time frame: Up to approximately 6 weeks

    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.

Secondary outcomes

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

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the AUC of sac-TIMT ADC

  2. Maximum Serum Concentration (Cmax) of sac-TMT ADC

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the Cmax of sac-TMT ADC

  3. Minimum Serum Concentration (Cmin) of sac-TMT ADC

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the Cmin of sac-TMT ADC

  4. Serum Apparent terminal half-life (t½) of sac-TMT ADC

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the t1/2 of sac-TMT ADC

  5. Serum AUC of sac-TMT Total Antibody (TAb)

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the AUC of sac-TMT Tab

  6. Serum Cmax of sac-TMT Tab

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the Cmax of sac-TMT Tab

  7. Serum Cmin of sac-TMT Tab

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the Cmin of sac-TMT Tab

  8. Serum t½ of sac-TMT Tab

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the t1/2 of sac-TMT Tab

  9. Plasma AUC of sac-TMT payload

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the AUC of sac-TMT payload

  10. Plasma Cmax of sac-TMT payload

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the Cmax of sac-TMT payload

  11. Plasma Cmin of sac-TMT payload

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the Cmin of sac-TMT payload

  12. Plasma t½ of sac-TMT payload

    Time frame: Up to approximately 6 weeks

    Blood samples will be collected to determine the t1/2 of sac-TMT payload

  13. Complete Response Rate (CRR)

    Time frame: Up to approximately 6 months

    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.

  14. Duration of Complete Response (DCR)

    Time frame: Up to approximately 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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)

Acronym: TroFuse-027

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 15, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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