RecruitingPhase 1Phase 2NCT07148128

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

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.


Sponsor

Auricula Biosciences Inc.

Enrollment

110 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called WEF-001 in adults with advanced solid tumors that have a specific genetic mutation called KRAS. KRAS mutations are common in several hard-to-treat cancers, and this drug is designed to target that mutation. **You may be eligible if...** - You are an adult with a KRAS-mutant advanced solid tumor — including pancreatic cancer, colorectal cancer, non-small cell lung cancer, ovarian cancer, cholangiocarcinoma, or bladder cancer - Your cancer has progressed after at least one standard treatment - You have at least one measurable tumor - You are in good physical condition (ECOG 0 or 1) **You may NOT be eligible if...** - You have an active serious infection - You have active heart disease or significant liver problems - You have untreated brain metastases - You have inflammatory bowel disease, lupus, or active uncontrolled thyroid disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGWEF-001

Starting dose of 0.3 mg/m2 q4wks IV, dose escalation


Locations(4)

NEXT Oncology Dallas

Dallas, Texas, United States

Next Oncology, San Antonio

San Antonio, Texas, United States

Princess Margareth Cancer Center

Toronto, Ontario, Canada

Oxford University Hospital

Headington, Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07148128


Related Trials