WEF-001 for advanced KRAS‑mutant solid tumors

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.

This trial will try WEF-001 alone in people with advanced KRAS‑mutant solid tumors (such as pancreatic, colorectal, or non‑small cell lung cancer) to check safety, dosing, and early signs it can shrink tumors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Auricula Biosciences Inc. (industry)
• Locations: 4 sites (Dallas, Texas and 3 other locations)
• Trial ID: NCT07148128 on ClinicalTrials.gov

What this trial studies

This Phase 1/2a, open‑label interventional trial gives WEF-001 as a single agent to adults with advanced or metastatic KRAS‑mutant solid tumors who have progressed after at least one standard therapy. The Phase 1 portion will focus on safety, tolerability and pharmacokinetics to identify appropriate dosing, followed by Phase 2a expansion cohorts to look for preliminary anti‑tumor activity using RECIST v1.1. Key eligibility includes measurable disease and ECOG performance status 0–1, while common exclusions include active infection, significant cardiovascular disease, untreated brain metastases, or severe liver dysfunction. Outcomes reported will include adverse events, PK parameters, and objective response signals to guide further development.

Who should consider this trial

Good fit: Adults with advanced or metastatic KRAS‑mutant solid tumors (including pancreatic adenocarcinoma, colorectal cancer, NSCLC, platinum‑resistant serous ovarian cancer, cholangiocarcinoma, or urothelial bladder cancer) who progressed after at least one standard therapy, have measurable disease, and ECOG 0–1 are the intended candidates.

Not a fit: Patients with uncontrolled infections, active cardiovascular disease, significant liver dysfunction, untreated brain metastases, recent lupus or other excluded comorbidities, or a concurrent active primary cancer are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, WEF-001 could become a new targeted treatment option that shrinks tumors or delays progression for some patients with KRAS‑mutant cancers.

How similar studies have performed: Some KRAS‑targeted drugs have shown benefit for specific mutation subtypes (for example KRAS G12C inhibitors), but broad activity across diverse KRAS‑mutant tumors remains limited, and WEF-001 represents a novel investigational approach.

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

Where this trial is running

Dallas, Texas and 3 other locations

• NEXT Oncology Dallas — Dallas, Texas, United States (RECRUITING)
• Next Oncology, San Antonio — San Antonio, Texas, United States (RECRUITING)
• Princess Margareth Cancer Center — Toronto, Ontario, Canada (RECRUITING)
• Oxford University Hospital — Headington, Oxford, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Michele Finn, MSc

Conditions: 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, Advanced or Metastatic KRAS-mutant Tumor, Antineoplastic Agents, Pancreatic Cancer, Colorectal Cancer