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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
No Placebo-Only Group
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.
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.
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 belowSelect...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
To assess the anti-tumor activity of REC-4881 as measured by to other efficacy endpoints
To characterize the PK of REC-4881
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Recursion Pharmaceuticals Inc.Lead Sponsor
5 Previous Clinical Trials
392 Total Patients Enrolled
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