NCT07148128 · Auricula Biosciences Inc.
Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
What this study is about
This is a study designed to assess the safety, tolerability, how the drug moves through the body and preliminary effectiveness of WEF-001 as treatment given alone in patients with Advanced KRAS-mutant solid tumours.
View original scientific description
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.
Interventions
DRUG
WEF-001
Starting dose of 0.3 mg/m2 q4wks IV, dose escalation
Primary outcome measures
Phase 1: To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy.
Time frame: Through study completion, an average of 1 year.
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.
Phase 2: To evaluate the antitumour activity following WEF-001 administration as monotherapy.
Time frame: Trough study completion, an average of 2 years.
Objective Response Rate according to Response Evaluation Criteria in Solid Tumor (RECIST) v 1.1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
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
- Dallas, Texas
- San Antonio, Texas
Collaborators
Simbec-Orion Group
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations