Clinical Trial 23598

• Overview

  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)

  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.

  Objective:

  Primary Objective: - To evaluate the safety and tolerability of intravesical (I-VESIC) sac-TMT monotherapy and to establish recommend Phase 2 dose (RP2D) Secondary Objective: - To characterize the systemic pharmacokinetic (PK) profile of I-VESIC sac-TMT monotherapy - To evaluate the efficacy of IVESIC sac-TMT with respect to complete response rate (CRR) based on local assessment - To evaluate the efficacy of IVESIC sac-TMT with respect to duration of CR based on local assessment

• Treatments

  Therapies:

  TROP2-targeted Antibody drug conjugate

  Medications:

  Sacituzumab tirumotecan ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • 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 (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.
  • Additional criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • 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.
  • Additional criteria may apply.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.