A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
Sponsor: Nimbus Wadjet, Inc.
ClinicalTrials ID:NCT06898450
Study 9216-101 is a Phase 1/2 trial assessing NDI-219216, a WRN helicase inhibitor, in patients with advanced solid tumors. Eligible participants have ECOG scores of 0-1, unresectable/metastatic tumors, and adequate organ function. The study evaluates safety, tolerability, pharmacokinetics, and preliminary antitumor activity through dose escalation and expansion phases.
Patient Parameters
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Program Overview
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.
Description
Study 9216-101 is a first-in-human (FIH), Phase 1/2, open-label, dose escalation, dose optimization, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-219216 in patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Have unresectable and/or metastatic solid tumors (with or without MSI-H/dMMR) refractory to or intolerant to previous SoC therapy or for which no SoC therapy exists
- Presence of measurable disease according to RECIST version 1.1 except for Part A (Dose Escalation)
- Adequate bone marrow / hematologic, end-organ, and cardiovascular function
- Resolution of all acute (or toxic) adverse effects of prior therapies, radiation therapy, or surgical procedures to Grade ≤ 1 (except fatigue, alopecia, and peripheral neuropathy).
Exclusion Criteria
- Clinically significant cardiovascular disease.
- Patients with known WRN syndrome.
- Pregnancy, breastfeeding, or intention of becoming 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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