A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
Public ClinicalTrials.gov record NCT06898450. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06898450
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 134 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 30, 2025
- Primary completion
- Sep 30, 2031
- Completion
- Nov 30, 2031
- Last update posted
- May 5, 2026
2025 – 2031
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90089 | Recruiting |
| University of Chicago Medicine | Chicago | Illinois | 60637 | Recruiting |
| University of Louisville James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | Recruiting |
| Cayuga Cancer Center | Ithaca | New York | 14850 | Terminated |
| Levine Cancer Center | Charlotte | North Carolina | 28204 | Recruiting |
| Atrium Health Wake Forest Baptist Center | Winston-Salem | North Carolina | 27157 | Recruiting |
| Taylor Cancer Research Center | Maumee | Ohio | 43537 | Recruiting |
| Brown University Health | Providence | Rhode Island | 02901 | Recruiting |
| Prisma Health Cancer Institute - Multidisciplinary Center | Greenville | South Carolina | 29605 | Recruiting |
| University of Virginia Emily Couric Clinical Cancer Center | Charlottesville | Virginia | 22908 | Recruiting |
| Virginia Cancer Specialists, P.C. - Fairfax | Fairfax | Virginia | 22031 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06898450, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06898450 live on ClinicalTrials.gov.