Trials / Recruiting
RecruitingNCT07148128
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.
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- Auricula Biosciences Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | WEF-001 | Starting dose of 0.3 mg/m2 q4wks IV, dose escalation |
Timeline
- Start date
- 2025-07-28
- Primary completion
- 2028-01-01
- Completion
- 2028-01-01
- First posted
- 2025-08-29
- Last updated
- 2026-01-29
Locations
4 sites across 3 countries: United States, Canada, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07148128. Inclusion in this directory is not an endorsement.