A Phase 1/2a Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors

• Research type

  Research Study

• Full title

  A Phase 1/2a, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients with Advanced KRAS G12D-Mutant Solid Tumors

• IRAS ID

  1013025

• Contact name

  Paul Orth

• Sponsor organisation

  Verastem Inc.

• Clinicaltrials.gov Identifier

  NCT07020221

• Research summary

  KRAS is a gene that plays an important role in helping cells grow and divide. Sometimes, this gene can develop specific changes, called mutations, that cause KRAS to stay "on" all the time. This can lead to uncontrolled cell growth, which may result in cancer. One common mutation in KRAS is called G12D, which is found in certain types of cancers, such as cancers in the pancreas, colon or rectum, and lungs.

  VS-7375 is a drug that was specifically developed to target the G12D mutation in KRAS. Targeting this mutation may slow down or stop cancer cell growth. VS-7375 is a tablet that is taken by mouth. Laboratory studies suggest VS-7375 may work to reduce the growth of cancer cells that have KRAS G12D mutations. VS-7375 is currently being tested in a clinical trial in China, but it is too early to understand the treatment effects of the drug.

  The main aims of this clinical study are to:
  • Find out the best dose of the study drug to use in patients when given alone and in combination with other approved treatments for cancer.
  • Understand the side effects and risks of VS-7375 alone and in combination with other cancer treatments.
  • Learn how well and how long VS-7375 alone or given with other cancer treatments may work to treat cancers with KRAS G12D mutations.
  • Measure the amount of VS-7375 in your blood at different times (this is called pharmacokinetics or PK).
  • Understand the impact of food on the PK, safety, and tolerability of VS-7375.
  The other cancer treatments to be used in this study are: cetuximab, carboplatin, pemetrexed, prembolizumab, nab-paclitaxel and gemcitabine

  A total of about 40 centres world wide will participate in this study. These centres are located in the US, Australia, France, Spain, Italy, Netherlands, Germany and the United Kingdom. In the UK 5 centres are participating. A total of 295 participants will participate in this study of which 25 in the UK.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  26/LO/0025

• Date of REC Opinion

  24 Mar 2026

• REC opinion

  Further Information Unfavourable Opinion