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

Sponsor: Auricula Biosciences Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07148128

This Phase 1/2a study evaluates WEF-001, administered intravenously at a starting dose of 0.3 mg/m² every four weeks with dose escalation, in patients with advanced KRAS-mutant solid tumors. Eligible participants must have progressive disease post-standard therapy, measurable disease per RECIST v1.1, and an ECOG performance status of 0 or 1.

Patient Parameters

Program Overview

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

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

FACILITYZIPCITYSTATE
NEXT Oncology Dallas75230DallasTexas
Next Oncology, San Antonio78229San AntonioTexas

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