Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedWEF-001

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 29, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Auricula Biosciences Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Auricula Biosciences Inc.
Interventions being studied: Drug: WEF-001

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Biomarkers

KRAS→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
ECOG ≤ 1

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

NEXT Oncology DallasDallas, Texas
Next Oncology, San AntonioSan Antonio, Texas
Princess Margareth Cancer CenterToronto, Ontario
Oxford University HospitalHeadington, Oxford

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 29, 2026. Always confirm current availability with the study team.

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