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Recruiting NCT06637423

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

Phase I / Phase II Interventional Non-Muscle Invasive Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sacituzumab tirumotecan, Rescue medication, Supportive care measures.
Who it may be relevant to
Registry conditions: Non-Muscle Invasive Bladder Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, France, Netherlands, Spain +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

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.

Interventions

  • Drug Sacituzumab tirumotecan
    Intravesical administration
  • Drug Rescue 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, an
  • Drug Supportive 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.

Primary outcome measures

  • Number of Participants with Dose Limiting Toxicity (DLT) [Time frame: Up to approximately 7 weeks]
  • Number of Participants Experiencing an Adverse Event (AE) [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 outcome measures (12)
  • Area Under the Serum Concentration-Time Curve (AUC) of sacituzumab tirumotecan (sac-TMT) Antibody-Drug Conjugate (ADC) [Time frame: Up to approximately 6 weeks]
  • Maximum Serum Concentration (Cmax) of sac-TMT ADC [Time frame: Up to approximately 6 weeks]
  • Minimum Serum Concentration (Cmin) of sac-TMT ADC [Time frame: Up to approximately 6 weeks]
  • Serum Apparent terminal half-life (t½) of sac-TMT ADC [Time frame: Up to approximately 6 weeks]
  • Serum AUC of sac-TMT Total Antibody (TAb) [Time frame: Up to approximately 6 weeks]
  • Serum Cmax of sac-TMT Tab [Time frame: Up to approximately 6 weeks]
  • Serum Cmin of sac-TMT Tab [Time frame: Up to approximately 6 weeks]
  • Serum t½ of sac-TMT Tab [Time frame: Up to approximately 6 weeks]
  • Plasma AUC of sac-TMT payload [Time frame: Up to approximately 6 weeks]
  • Plasma Cmax of sac-TMT payload [Time frame: Up to approximately 6 weeks]
  • Plasma Cmin of sac-TMT payload [Time frame: Up to approximately 6 weeks]
  • Plasma t½ of sac-TMT payload [Time frame: Up to approximately 6 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Michael G Oefelein Clinical Trials ( Site 0053) — Bakersfield
  • Moffitt Cancer Center ( Site 0057) — Tampa
  • Northwestern University ( Site 0051) — Chicago
  • Johns Hopkins University ( Site 0055) — Baltimore
France · 3 centers
  • Hôpital Claude Huriez ( Site 0012) — Lille
  • HENRI MONDOR HOSPITAL ( Site 0011) — Créteil
  • Gustave Roussy ( Site 0013) — Villejuif
Canada · 2 centers
  • Princess Margaret Cancer Centre ( Site 0003) — Toronto
  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospital — Sherbrooke
Spain · 2 centers
  • Hospital Universitario Virgen de la Victoria ( Site 0043) — Málaga
  • Hospital Universitario 12 de Octubre ( Site 0042) — Madrid
Netherlands · 1 center
  • Erasmus Medisch Centrum ( Site 0032) — Rotterdam
United Kingdom · 1 center
  • St Bartholomew s Hospital ( Site 0061) — London

Identifiers

NCT: NCT06637423 · 2870-027 · 2024-514983-23-00 · U1111-1308-6998 · MK-2870-027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗