← Back to searchRecruitingRecruiting
Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
NCT07148128 · Auricula Biosciences Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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.
About this study
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 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
Study design
Enrollment target: 110 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-28
Estimated completion: 2028-01
Last updated: 2026-01-29
Interventions
Drug: WEF-001
Primary outcomes
- • Phase 1: To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy. (Through study completion, an average of 1 year.)
- • Phase 2: To evaluate the antitumour activity following WEF-001 administration as monotherapy. (Trough study completion, an average of 2 years.)
Sponsor
Auricula Biosciences Inc. · industry
With: Simbec-Orion Group
Contacts & investigators
ContactMichele Finn, MSc · contact · inquiries@auriculabiosciences.com · 1-438-884-9551
All locations (4)
NEXT Oncology DallasRecruiting
Dallas, Texas, United States
Next Oncology, San AntonioRecruiting
San Antonio, Texas, United States
Princess Margareth Cancer CenterRecruiting
Toronto, Ontario, Canada
Oxford University HospitalRecruiting
Headington, Oxford, United Kingdom