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AXIN1 Cohort for Gene Mutation

Phase 2

Recruiting

Research Sponsored by Recursion Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed pre-dose and at multiple timepoints up to 24 months

Awards & highlights

Study Summary

This trial is being conducted at multiple centers and is open to participants with advanced or metastatic solid tumors that cannot be surgically removed. The purpose of the study is to examine the safety, effectiveness,

Who is the study for?

This trial is for adults with advanced solid tumors that can't be removed by surgery and have specific gene mutations (AXIN1 or APC). If they have colorectal cancer, it must not involve RAS/RAF mutations. Participants should have tried standard treatments without success or cannot tolerate them, and must be relatively active and able to care for themselves.Check my eligibility

What is being tested?

The study tests REC-4881, a drug taken orally at a dose of 12 mg daily. It aims to evaluate its safety, effectiveness, and how the body processes it in patients with certain genetic mutations who have advanced solid tumors.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones may include nausea, fatigue, allergic reactions to the medication itself or its components. Side effects could also relate to how the drug affects tumor growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active and can carry on all pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed pre-dose and at multiple timepoints up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed pre-dose and at multiple timepoints up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed pre-dose and at multiple timepoints up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the preliminary anti-tumor activity of REC-4881 as measured by Objective Response Rate (ORR)

To evaluate the safety and tolerability of REC-4881

Secondary outcome measures

To assess the anti-tumor activity of REC-4881 as measured by to other efficacy endpoints

To characterize the PK of REC-4881

Trial Design

2Treatment groups

Experimental Treatment

Group I: AXIN1 CohortExperimental Treatment1 Intervention

Participants will receive REC-4881 12mg PO dosed QD

Group II: APC CohortExperimental Treatment1 Intervention

Participants will receive REC-4881 12mg PO dosed QD

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Recursion Pharmaceuticals Inc.Lead Sponsor

3 Previous Clinical Trials

227 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different geographical areas can patients access this clinical trial?

"There are 49 available positions for patient recruitment in this trial. Notable locations include Beacon Health System in South Bend, Sharp HealthCare in San Diego, and Utah Cancer Specialists in Salt Lake City. Additionally, there are openings at 46 other sites across various locations."

Answered by AI

What level of risk does the AXIN1 Cohort pose to individuals?

"Based on our assessment, the safety of the AXIN1 Cohort is rated as a 2. As this trial belongs to Phase 2, there exists some data indicating its safety; however, no evidence has been found yet regarding efficacy."

Answered by AI

Are new patients still eligible to participate in this ongoing clinical trial?

"Based on the information provided by clinicaltrials.gov, this particular trial is no longer accepting candidates. The trial was posted on January 1st, 2024 and last updated on January 19th, 2024. However, it's important to note that there are currently 472 other ongoing clinical trials actively recruiting participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation

2024. "A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005974.

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