A study to investigate WEF-001 in patients with Advanced KRAS - Cancer

• Research type

  Research Study

• Full title

  An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumour Activity of WEF-001 in participants with Advanced KRAS-Mutant Solid Tumours.

• IRAS ID

  1011058

• Contact name

  Cynthia Cardinal

• Contact email

  cynthia.cardinal@auriculabiosciences.com

• Sponsor organisation

  Auricula Biosciences, Inc

• Eudract number

  2024-518644-21

• Research summary

  Rationale:
  Some types of cancers are harder to treat because of specific gene mutation that makes cancer grow uncontrollably. One of these genes is called KRAS. KRAS mutations play a significant role in many types of cancer, often leading to poor outcomes, especially in advanced stages. For e.g.
  • Over 90% of pancreatic cancers
  • 40% of colorectal cancers &
  • 25% of metastatic non-small cell lung cancers (NSCLC)
  This study focuses on a new drug, WEF-001, designed to target KRAS mutations more effectively while minimizing harm to healthy tissues.

  Objectives:
  The study aims to
  1. Test the safety and tolerability of WEF-001 in people with advanced KRAS-mutant cancers
  2. Determine how the body processes WEF-001 (pharmacokinetics)
  3. Evaluate the drug’s effectiveness in shrinking tumors

  Main Trial Endpoints:
  The primary focus is on
  • Monitoring side effects & determining safe dosage levels
  • Evaluating early signs of anti-tumor effects, like tumor shrinkage

  Secondary Endpoints:
  Additional goals include
  • Understanding how the drug behaves in the body (absorption, breakdown, etc.)
  • Measuring longer term tumor responses, such as how long patients remain stable or cancer free

  Trial Design:
  The trial has two parts
  1. Phase 1: Focuses on finding the safest dose by gradually increasing the amount given to small groups of patients. This is called dose escalation part.
  2. Phase 2a: Tests two selected doses in a larger group to evaluate the drug’s effectiveness. This is called Cohort (group) expansion.
  Participants will receive WEF-001 as an intravenous infusion on day 1 of every 28-day cycle. The trial includes monitoring periods before, during, & after treatment to assess its impact and safety.

  Trial Population:
  The trial includes both male & female adults with advanced KRAS-mutant cancers who have not responded well to previous treatments. Patients must be at least 18 years old & provide informed consent to participate.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  25/SC/0163

• Date of REC Opinion

  20 Jun 2025

• REC opinion

  Further Information Favourable Opinion