Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07148128

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

Led by Auricula Biosciences Inc. · Updated on 2026-01-29

110

Participants Needed

4

Research Sites

126 weeks

Total Duration

On this page

Sponsors

A

Auricula Biosciences Inc.

Lead Sponsor

S

Simbec-Orion Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of advanced KRAS-mutant solid tumor including pancreatic ductal adenocarcinoma, colorectal cancer, non-small cell lung cancer, platinum-resistant serous ovarian cancer, cholangiocarcinoma, or urothelial bladder cancer
  • Disease progression after at least one line of standard therapy
  • Measurable disease according to RECIST version 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Not Eligible

You will not qualify if you...

  • Active systemic infection requiring treatment within 28 days before the first dose
  • Active cardiovascular disease
  • Presence of a second active primary cancer needing systemic cancer therapy
  • Liver dysfunction
  • Untreated brain metastases or unstable neurological problems
  • Inflammatory bowel disease
  • Active and untreated hyperthyroidism
  • History of lupus erythematosus within the last 5 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

NEXT Oncology Dallas

Dallas, Texas, United States, 75230

Actively Recruiting

2

Next Oncology, San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

3

Princess Margareth Cancer Center

Toronto, Ontario, Canada

Actively Recruiting

4

Oxford University Hospital

Headington, Oxford, United Kingdom, 0X3 9DU

Actively Recruiting

Loading map...

Research Team

M

Michele Finn, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here