Status:
RECRUITING
Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
Lead Sponsor:
Auricula Biosciences Inc.
Collaborating Sponsors:
Simbec-Orion Group
Conditions:
Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma
Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07148128
Start Date
July 28 2025
End Date
January 1 2028
Last Update
October 14 2025
Active Locations (3)
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1
NEXT Oncology Dallas
Dallas, Texas, United States, 75230
2
Next Oncology, San Antonio
San Antonio, Texas, United States, 78229
3
Oxford University Hospital
Headington, Oxford, United Kingdom, 0X3 9DU