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

Not Applicable

Recruiting

• Conditions: Advanced or Metastatic KRAS-mutant Tumor; 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
• Interventions: Drug: WEF-001

• Registration Number: NCT07148128
• Lead Sponsor: Auricula Biosciences Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-25
• Study Start: 2025-07-28
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Primary Completion: 2028-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose selection	WEF-001	Phase 1: WEF-001 will be administered to participating patients at 1 selected dose out of 7 possible doses. Phase 2: WEF-001 will be administered to participating patients at 1 selected dose out of 2 possible doses.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

NEXT Oncology Dallas; 🇺🇸 Dallas, Texas, United States

Next Oncology, San Antonio; 🇺🇸 San Antonio, Texas, United States

Oxford University Hospital; 🇬🇧 Headington, Oxford, United Kingdom