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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors Cancer, MSI-H Cancer

In brief

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.

Key facts

Study ID

NCT06898450

Run by

Nimbus Wadjet, Inc.

People needed

134

Starts

2025-03-31

Expected to finish

2031-12-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Clinically significant cardiovascular disease.
• Patients with known WRN syndrome.
• Pregnancy, breastfeeding, or intention of becoming pregnant during the study.

Where it is running

• The Christie NHS Foundation Trust UK — Manchester, United Kingdom (enrolling)
• University of Chicago Medicine — Chicago, Illinois, United States (enrolling)
• University of Louisville James Graham Brown Cancer Center — Louisville, Kentucky, United States (enrolling)
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Levine Cancer Center — Charlotte, North Carolina, United States (enrolling)
• Atrium Health Wake Forest Baptist Center — Winston-Salem, North Carolina, United States (enrolling)
• Taylor Cancer Research Center — Maumee, Ohio, United States (enrolling)
• Brown University Health — Providence, Rhode Island, United States (enrolling)
• Prisma Health Cancer Institute - Multidisciplinary Center — Greenville, South Carolina, United States (enrolling)
• University of Virginia Emily Couric Clinical Cancer Center — Charlottesville, Virginia, United States (enrolling)
• Virginia Cancer Specialists, P.C. - Fairfax — Fairfax, Virginia, United States (enrolling)
• Liverpool Hospital — Liverpool, New South Wales, Australia (enrolling)
• Southern Oncology Clinical Research Unit — Bedford Park, South Australia, Australia (enrolling)
• Princess Margaret Cancer Center — Toronto, Ontario, Canada (enrolling)
• Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP) — Paris, France (enrolling)
• Centre Hospitalier Universitaire (CHU) de Poitiers — Poitiers, France (enrolling)
• START Dublin — Dublin, Ireland (enrolling)
• START Lisbon — Lisbon, Portugal (enrolling)
• START Barcelona — Barcelona, Spain (enrolling)
• Hospital Clinico San Carlos — Madrid, Spain (enrolling)
• Sarah Cannon Research Institute UK — London, United Kingdom (enrolling)
• Cayuga Cancer Center — Ithaca, New York, United States

Full record on ClinicalTrials.gov

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