Actively 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.
Led by Auricula Biosciences Inc. · Updated on 2026-01-29
110
Participants Needed
4
Research Sites
126 weeks
Total Duration
On this page
Sponsors
A
Auricula Biosciences Inc.
Lead Sponsor
S
Simbec-Orion Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of advanced KRAS-mutant solid tumor including pancreatic ductal adenocarcinoma, colorectal cancer, non-small cell lung cancer, platinum-resistant serous ovarian cancer, cholangiocarcinoma, or urothelial bladder cancer
- Disease progression after at least one line of standard therapy
- Measurable disease according to RECIST version 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Active systemic infection requiring treatment within 28 days before the first dose
- Active cardiovascular disease
- Presence of a second active primary cancer needing systemic cancer therapy
- Liver dysfunction
- Untreated brain metastases or unstable neurological problems
- Inflammatory bowel disease
- Active and untreated hyperthyroidism
- History of lupus erythematosus within the last 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
NEXT Oncology Dallas
Dallas, Texas, United States, 75230
Actively Recruiting
2
Next Oncology, San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
3
Princess Margareth Cancer Center
Toronto, Ontario, Canada
Actively Recruiting
4
Oxford University Hospital
Headington, Oxford, United Kingdom, 0X3 9DU
Actively Recruiting
Research Team
M
Michele Finn, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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