REC-4881 for Solid Tumors

Recruiting at 68 trial locations

Overseen By Recursion Pharmacueticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Recursion Pharmaceuticals Inc.

Must not be taking: MEK inhibitors

Disqualifiers: LVEF <50%

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Up to 24 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken another MEK inhibitor within two months before starting the trial.

Eligibility Criteria

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.

Inclusion Criteria

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

I am 18 or older with a specific type of advanced cancer that cannot be surgically removed.

My cancer has worsened or returned after treatment, or I can't tolerate standard cancer treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive REC-4881 (12 mg PO daily) for up to 2 years

Up to 24 months

Regular visits for tumor imaging and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• REC-4881

Trial Overview 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.

Participant Groups

Group I: AXIN1 Cohort Experimental Treatment 1 Intervention

Participants will receive REC-4881 12mg PO dosed QD

Group II: APC Cohort Experimental Treatment 1 Intervention

Participants will receive REC-4881 12mg PO dosed QD

REC-4881 is already approved in United States for the following indications:

Approved in United States as REC-4881 for:

• Familial Adenomatous Polyposis (FAP) - Orphan Drug Designation, not yet approved for any indication

Who Is Running the Clinical Trial?

Recursion Pharmaceuticals Inc.

Lead Sponsor

Trials

6

Recruited

450+