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

NCT06637423 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: 2870-0272024-514983-23-00U1111-1308-6998MK-2870-027
• Study Type: interventional
• Target: 32
• Locations: 6 countries
• Sites: 13

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.

Conditions

Non-Muscle Invasive Bladder Cancer

Keywords

Non-Muscle Invasive Bladder Cancer; Low Grade; Intermediate Risk; Recurrent Low-Grade

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (14)

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

  Up to approximately 6 weeks

• Maximum Serum Concentration (Cmax) of sac-TMT ADC

  Up to approximately 6 weeks

• Minimum Serum Concentration (Cmin) of sac-TMT ADC

  Up to approximately 6 weeks

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

  Up to approximately 6 weeks

• Serum AUC of sac-TMT Total Antibody (TAb)

  Up to approximately 6 weeks

Study Arms (1)

Sacituzumab tirumotecan

EXPERIMENTAL

Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks

Drug: Sacituzumab tirumotecan; Drug: Rescue medication; Drug: Supportive care measures

Interventions

Sacituzumab tirumotecan DRUG

Intravesical administration

Also known as: SKB264, sac-TMT, MK-2870

Sacituzumab tirumotecan

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.

Sacituzumab tirumotecan

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.

Sacituzumab tirumotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (13)

Michael G Oefelein Clinical Trials ( Site 0053)

Bakersfield, California, 93301, United States

RECRUITING

Moffitt Cancer Center ( Site 0057)

Tampa, Florida, 33612, United States

RECRUITING

Northwestern University ( Site 0051)

Chicago, Illinois, 60611, United States

RECRUITING

Johns Hopkins University ( Site 0055)

Baltimore, Maryland, 21287, United States

RECRUITING

Princess Margaret Cancer Centre ( Site 0003)

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CIUSSS de l'Estrie-CHUS ( Site 0002)

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Hôpital Claude Huriez ( Site 0012)

Lille, Nord, 59037, France

RECRUITING

HENRI MONDOR HOSPITAL ( Site 0011)

Créteil, Val-de-Marne, 94010, France

RECRUITING

Gustave Roussy ( Site 0013)

Villejuif, Val-de-Marne, 94805, France

RECRUITING

Erasmus Medisch Centrum ( Site 0032)

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Hospital Universitario Virgen de la Victoria ( Site 0043)

Málaga, Andalusia, 29010, Spain

RECRUITING

Hospital Universitario 12 de Octubre ( Site 0042)

Madrid, 28041, Spain

RECRUITING

St Bartholomew s Hospital ( Site 0061)

London, London, City of, EC1A 7BE, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (3); US (4); ES (2); GB (1); NL (1); CA (2)