Home › NCT06898450
A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
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
Who can join
Ages 18 to 99 · All sexes
Full 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.
About the study
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.
What is being tested
- NDI-219216 (drug)
Sponsor: Nimbus Wadjet, Inc. · Participants: 134 · Started: Mar 31, 2025
Contact the study team
- Sean Rossi · Phone: 857-600-8779
- Katie Ard, MSN · Phone: 303-646-7297
Official record on ClinicalTrials.gov — NCT06898450
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.