RecruitingPhase 1Phase 2NCT07148128
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.
Sponsor
Auricula Biosciences Inc.
Enrollment
110 participants
Start Date
Jul 28, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria8
- 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
Interventions
DRUGWEF-001
Starting dose of 0.3 mg/m2 q4wks IV, dose escalation
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07148128
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