Recruiting

WEF-001 for Advanced KRAS-Mutant Solid Tumors

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What is being tested

WEF-001

Drug
Who is being recruted

Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma
+2

+ Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer
+ Advanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung Cancer
Over 18 Years
+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2025

See protocol details

Summary

Principal SponsorAuricula Biosciences Inc.
Study ContactCynthia Cardinal CEO Auricula Biosciences, MSc, PharmD
Last updated: October 14, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 28, 2025Actual date on which the first participant was enrolled.

This study focuses on testing a new treatment called WEF-001 for people with advanced solid tumors that have a specific change in their KRAS gene. The goal is to understand how safe and tolerable this treatment is and to see how it behaves in the body. This research is important because KRAS mutations are challenging to treat, and finding effective therapies could greatly improve outcomes for patients dealing with these types of cancers. Participants in this study will receive WEF-001 as a single treatment. Researchers will observe how the drug is processed in the body and will monitor any potential side effects. The study also aims to gather early data on how well the treatment might work against the cancer. By focusing on safety and how the drug interacts with the body, the study aims to lay the groundwork for future research that could lead to better treatment options for patients with these difficult-to-treat tumors.

Official TitleAn 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. 
Principal SponsorAuricula Biosciences Inc.
Study ContactCynthia Cardinal CEO Auricula Biosciences, MSc, PharmD
Last updated: October 14, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
110 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
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
Criteria
4 inclusion criteria required to participate
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
8 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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.
Study Objectives
Primary Objectives

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.

Objective Response Rate according to Response Evaluation Criteria in Solid Tumor (RECIST) v 1.1

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Recruiting
NEXT Oncology DallasDallas, United StatesSee the location
Recruiting
Next Oncology, San AntonioSan Antonio, United States
Recruiting
Oxford University HospitalHeadington, United Kingdom
Recruiting
3 Study Centers