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

RECRUITINGPHASE1/PHASE2

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.

NCT07148128•Auricula Biosciences Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•ECOG ≤ 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

Locations (4)

NEXT Oncology Dallas

Dallas, Texas, United States

Next Oncology, San Antonio

San Antonio, Texas, United States

Princess Margareth Cancer Center

Toronto, Ontario, Canada

Oxford University Hospital

Headington, Oxford, United Kingdom

Key Dates

Start Date

July 28, 2025

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

January 29, 2026

Enrollment

110

ESTIMATED participants

Conditions

Advanced or Metastatic KRAS-mutant Tumor in Pancreatic AdenocarcinomaAdvanced or Metastatic KRAS-mutant Tumor in Colorectal CancerAdvanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung CancerAdvanced Solid TumorsAdvanced or Metastatic KRAS-mutant Tumor

Interventions

WEF-001

DRUG

Contacts

Michele Finn, MSc

CONTACT

1-438-884-9551 inquiries@auriculabiosciences.com