Phase Ia/Ib Study of GDC6036 In Advance KRASG12 Positive Cancers

• Research type

  Research Study

• Full title

  A PHASE Ia/Ib DOSE-ESCALATION AND DOSEEXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-6036 AS A SINGLE AGENT AND IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS WITH A KRAS G12C MUTATION

• IRAS ID

  292846

• Contact name

  Matthew Krebs

• Contact email

  matthew.krebs@christie.nhs.uk

• Sponsor organisation

  Genentech Inc

• Eudract number

  2020-000084-22

• Clinicaltrials.gov Identifier

  NCT04449874

• Clinicaltrials.gov Identifier

  147339, IND NUMBER:

• Duration of Study in the UK

  3 years, 8 months, 1 days

• Research summary

  Cancer occurs due to an abnormal growth of cells in the body. The KRAS gene is important in regulating cell growth and survival. Mutations (or errors in the genetic code) in the KRAS gene are commonly found in cancers and often associated with poor prognosis. One specific type of KRAS mutation, G12C, occurs in non-small cell lung cancer (a type of lung cancer), colorectal cancer (cancer of the bowels) and other solid tumours at a frequency of about ~12%, ~4% and ≤4%, respectively.
  GDC-6036 is a new drug specifically designed to target the G12C mutation of the KRAS gene. In mice models it slowed or stopped the growth of cancer cells. GDC-6036 is an experimental drug, which means health authorities have not approved it for the treatment of cancer either alone or in combination with other anti-cancer drugs, and it has not been tested in people prior to this study. This will be the first time that GDC-6036 will be given to humans.
  The drug will be tested by itself and in combination with other treatments relevant to specific cancer types. This is an open-label study, which means that you and your doctor will know the dose level of the study drug and study drug treatment to which you are assigned, and you will not be treated with a placebo (an inactive substance).
  The study is divided into two parts, stage I and stage II. In stage I, approximately 12 patients will receive the drug alone or in combination with another treatment to identify the best doses to use. When a safe and tolerable dose has been determined, approximately 20 patients will be enrolled in stage II.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  21/LO/0250

• Date of REC Opinion

  26 Apr 2021

• REC opinion

  Further Information Favourable Opinion