WEF-001 for Cancer

Recruiting at 3 trial locations

Overseen By Cynthia Cardinal CEO Auricula Biosciences, MSc, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Auricula Biosciences Inc.

Must not be taking: Anti-infectives, Cancer therapies

Disqualifiers: Cardiovascular, Liver dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called WEF-001, a potential drug for people with certain types of advanced cancer that have a specific mutation known as KRAS. The researchers aim to assess the safety and effectiveness of WEF-001 when taken alone. Participants will receive one of several possible doses to determine the optimal one. Individuals with a KRAS-mutant solid tumor, such as advanced lung or colorectal cancer, whose disease has progressed after other treatments, may be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that WEF-001 is likely to be safe for humans?

Research has shown that WEF-001 is being tested for safety and effectiveness in people with advanced KRAS-mutant solid tumors. As the trial is in its early stages, detailed safety results are not yet available. Researchers are still learning about the treatment's tolerance and potential side effects.

Currently, the main goals are to understand how the body processes the drug and to observe any negative effects. As this is an early phase trial, complete safety information may not yet be available, introducing some uncertainty for participants. However, the research team closely monitors the treatment for safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike many standard cancer treatments that rely on chemotherapy or radiation, WEF-001 targets cancer cells with a novel approach. Researchers are excited because WEF-001 uses a unique mechanism of action that selectively attacks cancer cells while minimizing damage to healthy tissue. This targeted approach could potentially reduce side effects and improve overall effectiveness compared to traditional therapies.

What evidence suggests that WEF-001 might be an effective treatment for advanced KRAS-mutant solid tumors?

Research has shown that WEF-001 could be a promising treatment for advanced cancers with a KRAS mutation. These mutations often make cancer more aggressive and harder to treat. Early findings suggest that WEF-001 specifically targets these mutations, potentially slowing or stopping tumor growth. Although limited data from human studies exist, early research is exploring the effectiveness of this treatment against these challenging cancers. By focusing on the KRAS gene, WEF-001 aims to provide a new option for patients with limited treatment choices. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors that have a specific mutation called KRAS. It's open to those who haven't had success with other treatments and are in good enough health to participate.

Inclusion Criteria

Measurable disease as defined by RECIST v1.1

My condition worsened after receiving standard treatment.

I can carry out all my self-care but not work activities.

Exclusion Criteria

I have liver problems.

I have an ongoing heart condition.

I have brain metastasis that hasn't been treated or unstable neurological symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Selection

Phase 1: WEF-001 will be administered to participating patients at 1 selected dose out of 7 possible doses.

1 year

Treatment

Phase 2: WEF-001 will be administered to participating patients at 1 selected dose out of 2 possible doses.

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• WEF-001

Trial Overview

The study is testing WEF-001 as a solo treatment. The goal is to see how safe it is, how the body processes it, and if it works against various cancers like colorectal, lung, pancreatic, and parotid gland cancer.

How Is the Trial Designed?

Group I: Dose selection Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Auricula Biosciences Inc.

Lead Sponsor

Simbec-Orion Group

Industry Sponsor

Trials

10

Recruited

690+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07148128

NCT07148128 | Phase 1/2a Study to Assess the Safety, ...

This is a study designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of WEF-001 as monotherapy in patients ...

2.

clinicaltrials.eu

clinicaltrials.eu/trial/study-of-wef-001-safety-and-effectiveness-in-patients-with-advanced-kras-mutant-solid-tumors/

Study of WEF-001 safety and effectiveness in patients with ...

This study focuses on patients with KRAS-mutant solid tumors, which are advanced forms of cancer that have a specific genetic change.

3.

patlynk.com

patlynk.com/trial/NCT07148128

WEF-001 for Advanced KRAS-Mutant Solid Tumors

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.

4.

withpower.com

withpower.com/trial/phase-2-colorectal-neoplasms-6-2025-a0310

WEF-001 for Cancer

This is a study designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of WEF-001 as monotherapy in patients with Advanced KRAS ...

5.

app.trialscreen.org

app.trialscreen.org/trials/phase-1-2-2a-to-assess-safety-tolerability-pharmacokinetics-preliminary-trial-nct07148128

Phase 1/2a Study to Assess the Safety, Tolerability ...

A Phase 1/2a study of WEF-001 in advanced KRAS-mutant solid tumors. A research study testing a new cancer drug called WEF-001 ... results, and make sure the study ...

6.

ctv.veeva.com

ctv.veeva.com/study/phase-1-2a-study-to-assess-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-w

Phase 1/2a Study to Assess the Safety, Tolerability ...

This is a study designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of WEF-001 as monotherapy in patients ...

7.

synapse.patsnap.com

synapse.patsnap.com/drug/f2a965918375494d97d13197e4f7977b

WEF-001 - Drug Targets, Indications, Patents

An Open-label, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of WEF-001 in Participants ...