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Brief Title: A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation
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
Study ID: NCT06005974
Brief 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.
Detailed Description: Approximately 60 individuals will be enrolled in this open-label Phase 2 study, allocated 1:1 between the 2 cohorts - AXIN1 mutation or APC mutation. The purpose of the study is to investigate the safety, efficacy, and pharmacokinetics of REC-4881 for the treatment of participants with unresectable locally advanced or metastatic solid tumors with either mutation. Participants will receive treatment with REC-4881 (12mg PO daily) for up to 2 years.
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Yuma Regional Medical Center, Yuma, Arizona, United States
Highlands Oncology, Springdale, Arkansas, United States
TOI Clinical Research, Cerritos, California, United States
Providence Medical Foundation (Fullerton), Fullerton, California, United States
MemorialCare, Long Beach, California, United States
Cancer and Blood Research Center, Los Alamitos, California, United States
Sharp HealthCare, San Diego, California, United States
Ridley-Tree Cancer Center, Santa Barbara, California, United States
Providence Medical Foundation (Santa Rosa), Santa Rosa, California, United States
Eastern Connecticut Hematology & Oncology Associates, Norwich, Connecticut, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
TOI Florida, Lakeland, Florida, United States
University Cancer & Blood Center, Athens, Georgia, United States
Hope and Healing Cancer Services, Hinsdale, Illinois, United States
Northwest Oncology & Hematology, Rolling Meadows, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Community Health Network, Indianapolis, Indiana, United States
Our Lady of the Lake, Baton Rouge, Louisiana, United States
The Center for Cancer and Blood Disorders, Germantown, Maryland, United States
Southcoast Centers for Cancer Care, Fairhaven, Massachusetts, United States
Mosaic Life Care, Saint Joseph, Missouri, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
OptumCare Cancer Care, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
New Jersey Cancer Care, Belleville, New Jersey, United States
Englewood Health, Englewood, New Jersey, United States
Summit Medical Group, Florham Park, New Jersey, United States
HOACNY, East Syracuse, New York, United States
Sanford Health - Fargo, Fargo, North Dakota, United States
Aultman Medical Group, Canton, Ohio, United States
TriHealth Cancer Institute, Cincinnati, Ohio, United States
The Toledo Clinic, Toledo, Ohio, United States
Ssm Health Care Of Oklahoma- Inc., Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute, Tulsa, Oklahoma, United States
Oregon Oncology Specialists, Salem, Oregon, United States
PCSRI - Gettysburg, Gettysburg, Pennsylvania, United States
Cancer Care Associates of York, York, Pennsylvania, United States
Bon Secours (Greenville) - St. Francis Cancer Center, Greenville, South Carolina, United States
Sanford Health, Sioux Falls, South Dakota, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Oncology Consultants, Houston, Texas, United States
Lumi Research, Sugar Land, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Hematology Oncology Associates of Fredericksburg, Fredericksburg, Virginia, United States
PeaceHealth, Bellingham, Washington, United States
Vista Oncology, Olympia, Washington, United States
Cancer Care Northwest, Spokane, Washington, United States
Northwest Medical Specialties, Tacoma, Washington, United States
ThedaCare, Appleton, Wisconsin, United States
Gundersen Health System, La Crosse, Wisconsin, United States