Clinical trial NCT06637423: A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Non-Muscle Invasive Bladder Cancer
Keywords: Non-Muscle Invasive Bladder Cancer
Low Grade
Intermediate Risk
Recurrent Low-Grade
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Number of Participants with Dose Limiting Toxicity (DLT)
timeFrame: Up to approximately 7 weeks
measure: Number of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to approximately 10 weeks
measure: Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)
timeFrame: Up to approximately 6 weeks
Secondary outcomes:
measure: Area Under the Serum Concentration-Time Curve (AUC) of sacituzumab tirumotecan (sac-TMT) Antibody-Drug Conjugate (ADC)
timeFrame: Up to approximately 6 weeks
measure: Maximum Serum Concentration (Cmax) of sac-TMT ADC
timeFrame: Up to approximately 6 weeks
measure: Minimum Serum Concentration (Cmin) of sac-TMT ADC
timeFrame: Up to approximately 6 weeks
measure: Serum Apparent terminal half-life (t½) of sac-TMT ADC
timeFrame: Up to approximately 6 weeks
measure: Serum AUC of sac-TMT Total Antibody (TAb)
timeFrame: Up to approximately 6 weeks
measure: Serum Cmax of sac-TMT Tab
timeFrame: Up to approximately 6 weeks
measure: Serum Cmin of sac-TMT Tab
timeFrame: Up to approximately 6 weeks
measure: Serum t½ of sac-TMT Tab
timeFrame: Up to approximately 6 weeks
measure: Plasma AUC of sac-TMT payload
timeFrame: Up to approximately 6 weeks
measure: Plasma Cmax of sac-TMT payload
timeFrame: Up to approximately 6 weeks
measure: Plasma Cmin of sac-TMT payload
timeFrame: Up to approximately 6 weeks
measure: Plasma t½ of sac-TMT payload
timeFrame: Up to approximately 6 weeks
measure: Complete Response Rate (CRR)
timeFrame: Up to approximately 6 months
measure: Duration of Complete Response (DCR)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Michael G Oefelein Clinical Trials ( Site 0053)
state: California
city: Chicago
country: United States
facility: Northwestern University ( Site 0051)
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University ( Site 0055)
state: Maryland
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie-CHUS ( Site 0002)
state: Quebec
city: Lille
country: France
facility: Hôpital Claude Huriez ( Site 0012)
state: Nord
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum ( Site 0032)
state: Zuid-Holland
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria ( Site 0043)
state: Andalucia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre ( Site 0042)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: