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Taking people in CanadaPhase 1/2

Tests WEF-001 in adults with advanced KRAS-mutant solid tumours

Tests WEF-001 alone in adults with advanced KRAS-mutant solid tumours.

Key facts

Who runs it
Auricula Biosciences Inc.
Where
Toronto, CanadaSee the siteAlso in 2 other countries, 3 sites
Registry title
Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
Status
Recruiting
Phase
Phase 1/2
People taking part
110 people, planned
Started
28 Jul 2025
Expected to end
Jan 2028
Type of study
Interventional
Treatments tested
  • WEF-001
Record updated
29 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced cancer that has a KRAS gene change. It tests the safety and early effect of a drug called WEF-001.

Age
18 years or older
Sex
All sexes can join
Disease stage
Advanced KRAS-mutant solid tumour: pancreatic ductal adenocarcinoma, colorectal cancer, non small cell lung cancer, platinum-resistant serous ovarian cancer, cholangiocarcinoma or urothelial bladder cancer. The disease must be measurable by RECIST v1.1. ECOG must be 1 or lower.
Earlier treatment
The cancer must have grown after at least one line of standard of care therapy.
Biomarker or test result
A KRAS mutation in the tumour

Main reasons for not taking part

  • Active infection needing anti-infective treatment within 28 days before the first dose
  • Active cardiovascular disease
  • A second active cancer needing systemic cancer treatment
  • Liver dysfunction
  • Untreated brain metastasis or unstable neurological dysfunction

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Advanced KRAS-mutant solid tumor: pancreatic ductal adenocarcinoma, colorectal cancer, non small cell lung cancer, platinum-resistant serous ovarian cancer, cholangiocarcinoma or urothelial bladder cancer
  • Progressive disease following at least one line of standard of care therapy
  • Measurable disease as defined by RECIST v1.1
  • ECOG ≤ 1

Who cannot take part

  • Active systemic infection requiring anti-infective therapy within 28 days prior to first dose of IMP
  • Active cardiovascular disease
  • Having a second active primary malignancy, requiring systemic administration of any cancer-related therapy
  • Inflammatory bowel disease
  • Liver dysfunction
  • Untreated brain metastasis and/or unstable neurological dysfunction
  • Active and untreated hyperthyroidism
  • Lupus erythematosus within past 5 years

Where in Canada

Also in 2 other countries, 3 sites

  • Princess Margareth Cancer CenterToronto, CanadaContact: Anna Spreafico, MD, PhD (principal investigator)Taking people

About the trial

What the trial wants to find out

This is a study designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of WEF-001 as monotherapy in patients with Advanced KRAS-mutant solid tumours.

The group in the trial

  • Dose selectionTreatment being tested

    Phase 1: WEF-001 will be administered to participating patients at 1 selected dose out of 7 possible doses. Phase 2: WEF-001 will be administered to participating patients at 1 selected dose out of 2 possible doses.

    Treatment: WEF-001

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of WEF-001 in Participants With Advanced KRAS- Mutant Solid Tumours.
Plain-language title
Tests WEF-001 in adults with advanced KRAS-mutant solid tumoursGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
29 January 2026