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A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

RecruitingPhase 1, Phase 2Ages 18 Years - 99 YearsAllNimbus Wadjet, Inc.
NCT06898450 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • NDI-219216
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Where

22 sites
USC Norris Comprehensive Cancer Center
Los Angeles, United States
University of Chicago Medicine
Chicago, United States
University of Louisville James Graham Brown Cancer Center
Louisville, United States
Cayuga Cancer Center
Ithaca, United States
Levine Cancer Center
Charlotte, United States
Atrium Health Wake Forest Baptist Center
Winston-Salem, United States
Taylor Cancer Research Center
Maumee, United States
Brown University Health
Providence, United States

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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