A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
A Phase 1/2 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
Nimbus Wadjet, Inc.
134 participants
Mar 31, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria3
- Clinically significant cardiovascular disease.
- Patients with known WRN syndrome.
- Pregnancy, breastfeeding, or intention of becoming pregnant during the study.
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Interventions
NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.
Locations(22)
View Full Details on ClinicalTrials.gov
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NCT06898450