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Phase 1/2a Study of WEF-001 for Advanced KRAS-Mutant Solid Tumors

This study is testing a new drug called WEF-001 for people with advanced solid tumors that have a specific genetic change called a KRAS mutation. This includes certain pancreatic, colorectal, and non-small cell lung cancers. You might be able to join if your cancer has progressed after at least one standard treatment and you have measurable disease. The study aims to find out how safe WEF-001 is, what side effects it might cause, and if it can shrink tumors. Researchers will also look at how the body handles the drug. The study plans to enroll about 110 participants.

Study design
This is an interventional study, meaning participants will receive the drug WEF-001. It is a Phase 1/2a study, which typically means it's an early-stage study looking at safety and initial effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for safety and tolerability for an average of 1 year, and for anti-tumor activity for an average of 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07148128

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
PHASE1Ages 18+InterventionalTreatment
Auricula Biosciences Inc.
~110 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:WEF-001

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy.
Measured over Through study completion, an average of 1 year.
+1 more outcome measured

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

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CholangiocarcinomaColorectal CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmPancreatic Ductal AdenocarcinomaSolid NeoplasmUrothelial Bladder CancerGTPase KRas

Where it's being run

4 sites across 3 states
Texas2
Ontario1
Oxford1

Who to contact

Michele Finn, MSc
[email protected]
1-438-884-9551
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Phase 1: To characterize the safety and tolerability profiles of WEF-001 administered as monotherapy.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.Trough study completion, an average of 2 years.

    Objective Response Rate according to Response Evaluation Criteria in Solid Tumor (RECIST) v 1.1