Study on the Safety and Effects of NDI-219216 for Patients with Advanced Solid Tumors
Sponsor: Nimbus Wadjet, Inc.
ClinicalTrials ID:NCT06898450
This clinical trial is testing a new drug, NDI-219216, to see if it is safe and effective for treating advanced solid tumors. The study will monitor side effects, how the drug affects the body, and whether it can reduce tumor size.
Patient Parameters
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Program Overview
The purpose of this study is to determine if the new drug NDI-219216 is safe for patients with advanced solid tumors and to explore its potential as a treatment option. The study will focus on understanding any side effects, how the drug interacts with the body, and its impact on tumor size. Participants will take the drug daily by mouth and attend regular clinic visits for checkups and tests. They will also keep a diary to track their medication intake and any symptoms they experience. After completing the study, a follow-up will be conducted, which can be done over the phone.
Description
This study, known as 9216-101, is the first time NDI-219216 is being tested in humans. It is a Phase 1/2 study, meaning it is in the early stages of testing. The study is open-label, so both the researchers and participants know what treatment is being given. The study will gradually increase the dose to find the best amount to use and will also look at how the drug behaves in the body and its initial effects on tumors. Participants will take NDI-219216 daily and visit the clinic frequently during the first cycle, then less often in later cycles. They will keep a diary of their medication use and any symptoms. The study aims to learn about the safety, tolerability, and potential effectiveness of NDI-219216 in treating advanced solid tumors.
Eligibility Criteria
Inclusion Criteria
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have advanced solid tumors that cannot be surgically removed or have spread to other parts of the body, and have not responded to or cannot tolerate standard treatments, or for which no standard treatment exists.
- Have measurable disease according to specific medical criteria, except for the initial dose escalation part of the study.
- Have adequate bone marrow, organ, and heart function as determined by medical tests.
- Have recovered from any side effects of previous treatments to a mild level, except for fatigue, hair loss, and nerve damage.
Exclusion Criteria
- Have significant heart disease.
- Have a known genetic condition called WRN syndrome.
- Be pregnant, breastfeeding, or planning to become pregnant during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| USC San Diego Health | 92093 | La Jolla | California |
| USC Norris Comprehensive Cancer Center | 90089 | Los Angeles | California |
| University of Chicago Medicine | 60637 | Chicago | Illinois |
| University of Louisville James Graham Brown Cancer Center | 40202 | Louisville | Kentucky |
| Cayuga Cancer Center | 14850 | Ithaca | New York |
| Taylor Cancer Research Center | 43537 | Maumee | Ohio |
| Brown University Health | 02901 | Providence | Rhode Island |
| Prisma Health Cancer Institute - Multidisciplinary Center | 29605 | Greenville | South Carolina |
| Tennessee Oncology | 37205 | Nashville | Tennessee |
| University of Virginia Emily Couric Clinical Cancer Center | 22908 | Charlottesville | Virginia |
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