WEF-001 for advanced KRAS‑mutant solid tumors
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.
Run by Auricula Biosciences Inc. · NCT07148128 · Data updated 2026-11-12
This trial will try WEF-001 alone in people with advanced KRAS‑mutant solid tumors (such as pancreatic, colorectal, or non‑small cell lung cancer) to check safety, dosing, and early signs it can shrink tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Auricula Biosciences Inc. Industry-sponsored |
| Locations | 4 sites (Dallas, Texas and 3 other locations) |
| Status | Recruiting |
| Started | July 28, 2025 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | January 29, 2026 |
| Trial ID | NCT07148128 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced or metastatic KRAS‑mutant solid tumors (including pancreatic adenocarcinoma, colorectal cancer, NSCLC, platinum‑resistant serous ovarian cancer, cholangiocarcinoma, or urothelial bladder cancer) who progressed after at least one standard therapy, have measurable disease, and ECOG 0–1 are the intended candidates.
✕Probably not a fit
Patients with uncontrolled infections, active cardiovascular disease, significant liver dysfunction, untreated brain metastases, recent lupus or other excluded comorbidities, or a concurrent active primary cancer are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1/2a, open‑label interventional trial gives WEF-001 as a single agent to adults with advanced or metastatic KRAS‑mutant solid tumors who have progressed after at least one standard therapy. The Phase 1 portion will focus on safety, tolerability and pharmacokinetics to identify appropriate dosing, followed by Phase 2a expansion cohorts to look for preliminary anti‑tumor activity using RECIST v1.1. Key eligibility includes measurable disease and ECOG performance status 0–1, while common exclusions include active infection, significant cardiovascular disease, untreated brain metastases, or severe liver dysfunction. Outcomes reported will include adverse events, PK parameters, and objective response signals to guide further development.
Why it matters
Potential benefit: If successful, WEF-001 could become a new targeted treatment option that shrinks tumors or delays progression for some patients with KRAS‑mutant cancers.
How similar studies have gone: Some KRAS‑targeted drugs have shown benefit for specific mutation subtypes (for example KRAS G12C inhibitors), but broad activity across diverse KRAS‑mutant tumors remains limited, and WEF-001 represents a novel investigational approach.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
NEXT Oncology Dallas
Dallas, Texas, United States Recruiting -
Next Oncology, San Antonio
San Antonio, Texas, United States Recruiting -
Princess Margareth Cancer Center
Toronto, Ontario, Canada Recruiting -
Oxford University Hospital
Headington, Oxford, United Kingdom Recruiting
Study contacts
- Study coordinator: Michele Finn, MSc
- Email: inquiries@auriculabiosciences.com
- Phone: 1-438-884-9551
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.