AXIN1 Gene MutationPhase 2NCT06005974
A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation
A Phase 2 study testing REC-4881 in people with AXIN1 Gene Mutation and APC Gene Mutation, run by Recursion Pharmaceuticals Inc. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- AXIN1 Gene Mutation, APC Gene Mutation, Solid Tumor
- What is being tested?
- REC-4881
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 13 sitesUnited States
- Study dates
- 15 Jan 2024to 24 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years of age or older with histologically-confirmed unresectable, locally advanced, or metastatic 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
- Have experienced progressive disease, relapsed 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
- Measurable disease at baseline per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Who cannot join
- Received treatment with another mitogen-activated protein kinase (MEK) inhibitor within two months of first dose of REC-4881
- Left ventricular ejection fraction (LVEF) <50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
Mary Crowley Cancer Research Centers
Dallas, Texas, 75231
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Mission Cancer And Blood
Des Moines, Iowa, 50314
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Cancer Specialists of North Florida
Fleming Island, Florida, 32003
Hunterdon Hematology Oncology
Hillsborough, New Jersey, 08844
Saint Luke's Hospital
Kansas City, Missouri, 64111
Medical Oncology Hematology Consultants
Newark, Delaware, 19713
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, 06360
Sharp Memorial Hospital
San Diego, California, 92123
Sansum Clinic
Santa Barbara, California, 93105
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
About this study
Official title: A Phase 2, Open Label Study of REC-4881 in Participants With Unresectable Locally Advanced or Metastatic Cancer With AXIN1 or APC Mutation
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.
- Conditions
- AXIN1 Gene Mutation, APC Gene Mutation, Solid Tumor
- Being tested
- REC-4881
- Keywords
- AXIN1, APC, Locally advanced or metastatic, Solid tumor
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REC-4881Drug
REC-4881 4mg capsules
| Study group | Role | What they receive |
|---|---|---|
| AXIN1 Cohort | Experimental | Participants will receive REC-4881 12mg PO dosed QD Receives: Drug: REC-4881 |
| APC Cohort | Experimental | Participants will receive REC-4881 12mg PO dosed QD Receives: Drug: REC-4881 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicities
Measured: Up to 24 months
Objective Response Rate
Measured: Up to 24 months
Secondary outcomes (5)
Area Under the Plasma Concentration-time Curve (AUC) of REC-4881
Measured: pre-dose and up to 24 months
Disease Control Rate
Measured: Up to 24 months
Duration of response
Measured: Up to 24 months
Duration of Stable Disease
Measured: Up to 24 months
Time to Response
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start15 Jan 2024
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Why it stopped: Study was terminated due to sponsor decision. This decision was not related to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AXIN1 Gene MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recursion Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005974
- Sponsor's protocol ID
- REC-4881-221
- Status last verified
- Feb 2026
- First submitted
- 10 Aug 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open Label Study of REC-4881 in Participants With Unresectable Locally Advanced or Metastatic Cancer With AXIN1 or APC Mutation
- ClinicalTrials.gov ID
- NCT06005974
- Acronym / sponsor ID
- REC-4881-221
- Conditions
- AXIN1 Gene Mutation, APC Gene Mutation, Solid Tumor
- Keywords
- AXIN1, APC, Locally advanced or metastatic, Solid tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to sponsor decision. This decision was not related to safety concerns.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Recursion Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| AXIN1 Cohort | Experimental | Drug: REC-4881Participants will receive REC-4881 12mg PO dosed QD |
| APC Cohort | Experimental | Drug: REC-4881Participants will receive REC-4881 12mg PO dosed QD |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 55 years of age or older with histologically-confirmed unresectable, locally advanced, or metastatic 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
- Have experienced progressive disease, relapsed 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
- Measurable disease at baseline per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Key exclusion criteria (2 listed)
- Received treatment with another mitogen-activated protein kinase (MEK) inhibitor within two months of first dose of REC-4881
- Left ventricular ejection fraction (LVEF) <50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REC-4881REC-4881 4mg capsules | Drug | APC Cohort, AXIN1 Cohort |
Primary outcome
Number of Participants with Dose Limiting Toxicities
Time frame: Up to 24 months
Objective Response Rate
Time frame: Up to 24 months
5 secondary outcomes
Area Under the Plasma Concentration-time Curve (AUC) of REC-4881
Time frame: pre-dose and up to 24 months
Disease Control Rate
Time frame: Up to 24 months
Duration of response
Time frame: Up to 24 months
Duration of Stable Disease
Time frame: Up to 24 months
Time to Response
Time frame: Up to 24 months
Results and safety
The study was stopped early (reason given: Study was terminated due to sponsor decision. This decision was not related to safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REC-4881 in people with AXIN1 Gene Mutation and APC Gene Mutation, run by Recursion Pharmaceuticals Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to sponsor decision. This decision was not related to safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose Limiting Toxicities (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.