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NCT07148128PHASE1, PHASE2Recruiting

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

Auricula Biosciences Inc.

Start Date

7/28/2025

Completion Date

1/1/2028

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

WEF-001

Interested in This Trial?

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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

Locations

NEXT Oncology Dallas

Dallas, Texas 75230

United States

Next Oncology, San Antonio

San Antonio, Texas 78229

United States

Princess Margareth Cancer Center

Toronto, Ontario

Canada

Oxford University Hospital

Headington, Oxford 0X3 9DU

United Kingdom