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Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: WEF-001 (drug)
How long the study runs: Study runs about 30 months (dates as stated)
About the drug or intervention: WEF-001 — drug: Starting dose of 0.3 mg/m2 q4wks IV, dose escalation
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 110
Started: 2025-07-28
Last checked: 2026-01

Plain English Summary

What is this study?

• Testing a new treatment for advanced or metastatic kras-mutant tumor in pancreatic adenocarcinoma
• Phase1/Phase2 - 110 participants
• 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

Who can take part?

• Ages 18 Years and over
• Diagnosed with advanced or metastatic kras-mutant tumor in pancreatic adenocarcinoma

Where?

• Headington - Oxford University Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Advanced or Metastatic KRAS-mutant Tumor in Pancreatic AdenocarcinomaAdvanced or Metastatic KRAS-mutant Tumor in Colorectal CancerAdvanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung CancerAdvanced Solid TumorsAdvanced or Metastatic KRAS-mutant Tumor

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders
How fit you need to be: ECOG 1 or better

Biomarkers mentioned

KRAS

What the study is looking for

✓Progressive disease following at least one line of the usual treatment therapy
✓cancer that can be measured on scans as defined by (standard scan measurements)
✓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 cancer, requiring systemic administration of any cancer-related therapy
✗Liver dysfunction
✗Untreated brain metastasis and/or unstable neurological dysfunction

See the full criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Liver dysfunction * Untreated brain metastasis and/or unstable neurological dysfunction * Inflammatory bowel disease * Active and untreated hyperthyroidism * Lupus erythematosus within past 5 years

Where Is This Study? (1 UK site)

Oxford University Hospital

Headington 0X3 9DU, United Kingdom

Recruiting

Site contact (verified)

Mark Middleton, MD, FRCP (UK), PhDPrincipal Investigator

How to Get in Touch

Michele Finn, MSc

Sponsor contact

CONTACT

1-438-884-9551 inquiries@auriculabiosciences.com

Data sourced from ClinicalTrials.gov · Last verified: 2026-01