NCT07148128RecruitingPhase 1/2
Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
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.
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 25 Jun 2025
- Start date
- 28 Jul 2025
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Auricula Biosciences Inc.
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT07148128
- EudraCT number
- 2024-518644-21
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 110
- From 28 Jul 2025 to the primary completion date, 31 Jan 2028
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active systemic infection requiring anti-infective therapy within 28 days prior to first dose of IMP
Other illness
- Active cardiovascular disease
- Having a second active primary malignancy, requiring systemic administration of any cancer-related therapy
- Inflammatory bowel disease
Other
- Liver dysfunction
- Untreated brain metastasis and/or unstable neurological dysfunction
- Active and untreated hyperthyroidism
- Lupus erythematosus within past 5 years
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margareth Cancer Center Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Oxford University Hospital Coordinator of this site? Confirm its status | Headington | United Kingdom | Recruiting |
| NEXT Oncology - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| NEXT Oncology San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.