Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
Recruiting now · Phase 1/Phase 2
Conditions studied: Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma, Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer, Advanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung Cancer, Advanced Solid Tumors, Advanced or Metastatic KRAS-mutant Tumor
In brief
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.
Key facts
- Study ID
- NCT07148128
- Run by
- Auricula Biosciences Inc.
- People needed
- 110
- Starts
- 2025-07-28
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-01-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- NEXT Oncology Dallas — Dallas, Texas, United States (enrolling)
- Next Oncology, San Antonio — San Antonio, Texas, United States (enrolling)
- Princess Margareth Cancer Center — Toronto, Ontario, Canada (enrolling)
- Oxford University Hospital — Headington, Oxford, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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