A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors. (NCT06898450)
A Phase 1 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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: USC Norris Comprehensive Cancer Center — Los Angeles, California
Age range: 18 Years to 99 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- University of Chicago Medicine — Chicago, Illinois
- University of Louisville James Graham Brown Cancer Center — Louisville, Kentucky
- Cayuga Cancer Center — Ithaca, New York
- Levine Cancer Center — Charlotte, North Carolina
- Atrium Health Wake Forest Baptist Center — Winston-Salem, North Carolina
- Taylor Cancer Research Center — Maumee, Ohio
- Brown University Health — Providence, Rhode Island
- Prisma Health Cancer Institute - Multidisciplinary Center — Greenville, South Carolina
- University of Virginia Emily Couric Clinical Cancer Center — Charlottesville, Virginia
- Virginia Cancer Specialists, P.C. - Fairfax — Fairfax, Virginia
- Liverpool Hospital — Liverpool, New South Wales
- Southern Oncology Clinical Research Unit — Bedford Park, South Australia
- Princess Margaret Cancer Center — Toronto, Ontario
- Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP) — Paris,
- Centre Hospitalier Universitaire (CHU) de Poitiers — Poitiers,
- START Dublin — Dublin,
- START Lisbon — Lisbon,
- START Barcelona — Barcelona,
- Hospital Clinico San Carlos — Madrid,
- Sarah Cannon Research Institute UK — London,
- The Christie NHS Foundation Trust UK — Manchester,
📞 Contact the Study Coordinator
Phone: (857) 600-8779
Email: sean.rossi@nimbustx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Solid Tumors Cancer
- A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors — Scottsdale, Arizona
- Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors — Boston, Massachusetts
- Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors — Springdale, Arkansas
- A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors — Los Angeles, California
- ORB-021 In Patients With Advanced Solid Tumors — Scottsdale, Arizona
Explore by condition: All Advanced Solid Tumors Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.