A Phase 1/2 interventional study of WEF-001 in Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma, Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer and Advanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung Cancer, sponsored by Auricula Biosciences Inc.. Recruiting at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Auricula Biosciences Inc. · Phase 1/2, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's planned enrollment of 110 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →This is the only study on the registry with Auricula Biosciences Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Phase 1: WEF-001 will be administered to participating patients at 1 selected dose out of 7 possible doses. Phase 2: WEF-001 will be administered to participating patients at 1 selected dose out of 2 possible doses.
Drug: WEF-001
Starting dose of 0.3 mg/m2 q4wks IV, dose escalation
Also known as: MMAE-Drug Conjugate
Phase 1: To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy.
Type, incidence and severity of TEAEs, SAEs and abnormal laboratory values per CTCAE v5.0. Frequency of dose interruptions, reductions, and discontinuations. Proportion of participants with DLTs at each dose level.
Time frame: Through study completion, an average of 1 year.
Phase 2: To evaluate the antitumour activity following WEF-001 administration as monotherapy.
Objective Response Rate according to Response Evaluation Criteria in Solid Tumor (RECIST) v 1.1
Time frame: Trough study completion, an average of 2 years.
Plan to share: No
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