A Phase 1/2 study of MK-2870 in participants with GI cancer

• Research type

  Research Study

• Full title

  A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers

• IRAS ID

  1009608

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06428409

• Research summary

  MK-2870, the trial medicine, is an antibody drug conjugate (ADC) that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. In addition, MK-2870 triggers the body’s own immune cells to kill tumour cells. Therefore, MK-2870 may provide a targeted therapy that could possibly improve effectiveness and tolerability in treatment of gastrointestinal cancers.
  This trial is testing MK-2870 alone or in combination with chemotherapy fluorouracil (5-FU) and either leucovorin (LV) or levoleucovorin in people with the following gastrointestinal cancers:
  • Colorectal cancer (CRC)
  • Pancreatic ductal adenocarcinoma (PDAC)
  • Biliary tract cancer (BTC)
  Approximately 130 eligible participants will be assigned to 2 different treatment arms based on the specific type of cancer they have:
  • Arm A: Cohort 1: Participants with second Line (2L) CRC will receive MK-2870 in combination with chemotherapy.
  • Arm B – will be divided into 2 cohorts:
  o Cohort 2: Participants with second line (2L) PDAC will receive MK-2870 alone
  o Cohort 3: Participants with second line or later (2L+) BTC will receive MK-2870 alone
  MK-2870 is an experimental drug. It has not been approved to treat any type of cancer. The combination of MK-2870 with other drugs is also considered experimental. Dependent on the type of cancer, participants will receive either MK-2870 alone or in combination with fluorouracil and either leucovorin (LV) or levoleucovorin by intravenous infusion (IV) every 2 weeks for approximately to 27 rounds of trial medication. Participants on this trial will participate for approximately 5 years, consisting of approximately 2 years of treatment and 3 years of follow up.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  24/LO/0256

• Date of REC Opinion

  4 Jul 2024

• REC opinion

  Further Information Favourable Opinion