Clinical trial of sac-TMT (MK-2870) given directly into the bladder for non-muscle invasive bladder

• Research type

  Research Study

• Full 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)

• IRAS ID

  1010715

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06637423

• Research summary

  Researchers are looking for new ways to treat people with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC).
  Doctors often use a surgery called trans urethral resection of bladder tumour (TURBT) to treat IR NMIBC but, TURBT can be hard for people to tolerate due to the need for anesthesia, risk of bleeding and trauma to the bladder.

  Researchers want to know if sacituzumab tirumotecan (sac-TMT, also called MK-2870) can treat NMIBC when given in the bladder. Sac-TMT, the study medicine, is an antibody¬–drug conjugate (ADC) which attaches to certain targets on cancer cells and delivers medicine to destroy those cells.
  About 32 people will be in this study. They will be at least 18 years old and:
  • Have low-grade NMIBC that came back after treatment
  • Do not have certain health problems

  Everyone in the study receives sac-TMT in the bladder as a liquid through a thin tube (called a catheter) once a week for 6 weeks.
  To prevent reactions from receiving sac-TMT in the bladder, people may receive other medicines before receiving the study medicine.
  Researchers will assign people to 1 of 4 dose levels of sac-TMT. They will start by giving the lowest dose level to the first group, then checking to see if there are any safety concerns before giving a higher dose to the next group. This will continue until researchers give the highest dose level.

  Both the people in the study and the researchers will know the study medicine and dose level the person receives.
  During the study, people may give blood and urine samples, have imaging tests, have physical examinations and may have a cystoscopy (procedure that uses a thin tube with a camera to see inside the bladder and the urethra) or a biopsy, where a small sample of tissue is taken for testing.

  People may be in this study for about 2 years.

  The trial is sponsored by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  24/SC/0352

• Date of REC Opinion

  29 Jan 2025

• REC opinion

  Further Information Favourable Opinion