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A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
Sponsor: Nimbus Wadjet, Inc.
Summary
The goal of this clinical trial is to learn if NDI-219216 is safe for patients, and if NDI-219216 might be a possible treatment for advanced solid tumors in the later phases of the study. The main questions it aims to answer are: Is NDI-219216 safe and what kinds of side effects might it cause? What kind of effects does NDI-219216 have on the body? Does NDI-219216 have any impact on tumor size? Participants will: Take NDI-219216 every day by mouth. Visit the clinic 6 times during Cycle 1, 2 times during Cycle 2, once a month thereafter for checkups and tests while on the study, then one time for an end of treatment visit. After the End of Study, a follow up will occur but can be done on the phone. Keep a diary of their tablet consumption and symptoms experienced.
Official title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NDI-219216 in Patients With Advanced Solid Tumors With/Without Microsatellite Instability and/or Deficient Mismatch Repair
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2025-03-31
Completion Date
2031-12
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
NDI-219216
NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.
Locations (29)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Chicago Medicine
Chicago, Illinois, United States
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States
Cayuga Cancer Center
Ithaca, New York, United States
Levine Cancer Center
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Center
Winston-Salem, North Carolina, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
Brown University Health
Providence, Rhode Island, United States
Prisma Health Cancer Institute - Multidisciplinary Center
Greenville, South Carolina, United States
University of Virginia Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States
Virginia Cancer Specialists, P.C. - Fairfax
Fairfax, Virginia, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
BC Cancer Center
Kelowna, British Columbia, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, France
START Dublin
Dublin, Ireland
START Lisbon
Lisbon, Portugal
CHA University-Bundang Medical Centre
Seongnam-si, Gyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
START Barcelona
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Beatson Clinical Research Facility
Glasgow, United Kingdom
Sarah Cannon Research Institute UK
London, United Kingdom
The Christie NHS Foundation Trust UK
Manchester, United Kingdom