REC-4881 for Solid Tumors

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called REC-4881 for certain advanced solid tumors that cannot be surgically removed. Researchers aim to determine if REC-4881 is safe and effective for tumors with specific genetic mutations, namely AXIN1 or APC. The trial is open to individuals with these mutations who have not responded well to other cancer treatments. Those with colorectal cancer must not have certain other genetic mutations to participate. Participants will take a daily dose of the medication to assess its effectiveness in managing their cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that REC-4881 is likely to be safe for humans?

Research has shown that REC-4881 is generally well-tolerated. In earlier studies with 19 patients, most side effects were mild and not serious, resembling minor annoyances. Some more serious side effects occurred, but these were less common. The safety profile of REC-4881 aligns with other drugs in its group, known as MEK1/2 inhibitors, which have been in use for some time. This suggests that REC-4881 has a reliable safety record so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike most treatments for solid tumors, which typically target cancer cells directly with chemotherapy or radiation, REC-4881 is unique because it focuses on a specific pathway involving the AXIN1 and APC genes. This approach aims to interrupt the signaling pathways that help tumors grow, potentially offering a more targeted therapy with fewer side effects. Researchers are excited because REC-4881's mechanism could lead to more precise and effective treatments, particularly for patients whose tumors have mutations in these pathways.

What evidence suggests that REC-4881 might be an effective treatment for solid tumors?

Research shows that REC-4881 has potential in treating certain health issues. In earlier studies on familial adenomatous polyposis (FAP), REC-4881 reduced the number of polyps by 43% over 13 weeks. This suggests that REC-4881 can significantly manage diseases. Although these findings come from a different condition, they offer hope that REC-4881 might also work for solid tumors with AXIN1 or APC mutations. In this trial, participants will receive REC-4881 in either the AXIN1 Cohort or the APC Cohort, based on their specific tumor mutations. This hope stems from its ability to reduce abnormal growths in other conditions. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06005974

NCT06005974 | A Study of REC-4881 in Participants with ... This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses)

2. seekingalpha.com seekingalpha.com/article/4814775-recursion-hold-rating-based-on-initial-rec-4881-fap-treatment-data

Recursion: "Hold" Rating Based On Initial REC-4881 FAP ... REC-4881 demonstrated significant polyp reduction in most FAP patients, yet one non-responder raises questions about its future potential.

3. ir.recursion.com ir.recursion.com/news-releases/news-release-details/preliminary-phase-1b2-data-rec-4881-familial-adenomatous

Preliminary Phase 1b/2 Data for REC-4881 in Familial ... In the interim Phase 2 analysis, REC-4881 (4 mg QD) demonstrated a preliminary median 43% reduction in polyp burden at Week 13 among efficacy- ...

4. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/rec-4881-fap-study-shows-reduced-polyp-burden/

Rec-4881 FAP Study Shows Reduced Polyp Burden A 43% reduction in polyp burden at just 13 weeks suggests REC-4881 could significantly alter disease management and improve patient outcomes.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06005974?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(%22Adenomatous%20Polyposis%20Coli%22)%20AND%20AREA%5BBasicSearch%5D(gene%20therapy)))))&rank=1

A Study of REC-4881 in Participants with Cancers Which ... The purpose of the study is to investigate the safety, efficacy, and pharmacokinetics of REC-4881 for the treatment of participants with unresectable locally ...