A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
NCT ID: NCT06898450
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
134 participants
INTERVENTIONAL
2025-03-31
2031-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A dose escalation
Part A Dose Escalation will involve enrolling sequential cohorts with increasing doses of NDI-219216 administered daily in repeating 28-day treatment cycles. The Dose Limiting Toxicity review period for each cohort will be 21 days for each patient enrolled, with review by a Safety Review Committee prior to escalation to the next dose level.
NDI-219216
NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.
Part B Project Optimus
Part B will enroll up to 3 cohorts of patients randomized between up to 3 dose levels determined from Part A Dose Escalation. NDI-219216 will be administered daily in repeating 28-day treatment cycles.
NDI-219216
NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.
Part C Dose Expansion
Part C will enroll 2 groups of patients with dMMR/MSI-h status and other select criteria, utilizing the optimal dose identified from Part B. NDI-219216 will be administered daily in 28-day repeating cycles.
NDI-219216
NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.
Interventions
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NDI-219216
NDI-219216 is a highly selective small molecule inhibitor of WRN helicase activity.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with known WRN syndrome.
* Pregnancy, breastfeeding, or intention of becoming pregnant during the study.
18 Years
99 Years
ALL
No
Sponsors
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Worldwide Clinical Trials
OTHER
Nimbus Wadjet, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anita Scheuber, MD, PhD
Role: STUDY_DIRECTOR
Nimbus Therapeutics, Inc.
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Chicago Medicine
Chicago, Illinois, United States
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States
Cayuga Cancer Center
Ithaca, New York, United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
Brown University Health
Providence, Rhode Island, United States
Prisma Health Cancer Institute - Multidisciplinary Center
Greenville, South Carolina, United States
University of Virginia Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States
Virginia Cancer Specialists, P.C. - Fairfax
Fairfax, Virginia, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
BC Cancer Center
Kelowna, British Columbia, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, , France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, , France
START Dublin
Dublin, , Ireland
START Lisbon
Lisbon, , Portugal
START Barcelona
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Beatson Clinical Research Facility
Glasgow, , United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
The Christie NHS Foundation Trust UK
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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9216-101
Identifier Type: -
Identifier Source: org_study_id
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