ClinicalTrials.gg
TerminatedNCT06005974Updated Feb 23, 2026

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

A Phase 2 interventional study of REC-4881 in AXIN1 Gene Mutation, APC Gene Mutation and Solid Tumor, sponsored by Recursion Pharmaceuticals Inc.. Terminated at 13 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by Recursion Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
Study was terminated due to sponsor decision. This decision was not related to safety concerns.

From the registry’s dates

  • Primary completion was Feb 2025, 1 year 8 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Feb 2026.
Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
55 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • AXIN1 Gene Mutation
  • APC Gene Mutation
  • Solid Tumor

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Keywords

  • AXIN1
  • APC
  • Locally advanced or metastatic
  • Solid tumor
03

In context

Neoplasm Metastasis

4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.

This study's enrollment of 18 is below the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Recursion Pharmaceuticals Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 55 years of age or older with -confirmed unresectable, locally advanced, or solid tumor with AXIN1 or APC mutation. If a participant has colorectal cancer, then they must be RAS / RAF wild type to enroll into the APC mutant cohort
  2. Have experienced progressive disease, disease, or be intolerant to at least one established standard systemic anti-cancer treatment, or in the opinion of the Investigator have been considered ineligible for standard therapy
  3. at baseline per 1.1 criteria
  4. (ECOG) performance status ≤ 1

Exclusion criteria

Exclusion Criteria:

  1. Received treatment with another mitogen-activated protein kinase (MEK) inhibitor within two months of first dose of REC-4881
  2. (LVEF) \<50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    AXIN1 Cohort

    Participants will receive REC-4881 12mg PO dosed QD

    Drug: REC-4881

  • Experimental
    APC Cohort

    Participants will receive REC-4881 12mg PO dosed QD

    Drug: REC-4881

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Participants with Dose Limiting Toxicities

    Time frame: Up to 24 months

  2. Objective Response Rate

    Time frame: Up to 24 months

Secondary outcomes

  1. Area Under the Plasma Concentration-time Curve (AUC) of REC-4881

    Time frame: pre-dose and up to 24 months

  2. Disease Control Rate

    Time frame: Up to 24 months

  3. Duration of response

    Time frame: Up to 24 months

  4. Duration of Stable Disease

    Time frame: Up to 24 months

  5. Time to Response

    Time frame: Up to 24 months

07

Study locations

13 sites
  • Sharp Memorial Hospital
    San Diego, California 92123, United States
  • Sansum Clinic
    Santa Barbara, California 93105, United States
  • Rocky Mountain Cancer Centers
    Denver, Colorado 80218, United States
  • Eastern Connecticut Hematology & Oncology Associates
    Norwich, Connecticut 06360, United States
  • Medical Oncology Hematology Consultants
    Newark, Delaware 19713, United States
  • Cancer Specialists of North Florida
    Fleming Island, Florida 32003, United States
  • Mission Cancer And Blood
    Des Moines, Iowa 50314, United States
  • American Oncology Partners of Maryland, PA
    Bethesda, Maryland 20817, United States
  • Saint Luke's Hospital
    Kansas City, Missouri 64111, United States
  • Hunterdon Hematology Oncology
    Hillsborough, New Jersey 08844, United States
  • Avera Cancer Institute
    Sioux Falls, South Dakota 57105, United States
  • Mary Crowley Cancer Research Centers
    Dallas, Texas 75231, United States
  • Virginia Cancer Specialists
    Fairfax, Virginia 22031, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06005974
Lead sponsor
Recursion Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Aug 23, 2023
Start date
Jan 15, 2024
Primary completion
Feb 24, 2025
Completion
Feb 24, 2025
Last update
Feb 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: TAK 733

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