Actively Recruiting
A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
Led by Nimbus Wadjet, Inc. · Updated on 2026-05-06
134
Participants Needed
22
Research Sites
348 weeks
Total Duration
On this page
Sponsors
N
Nimbus Wadjet, Inc.
Lead Sponsor
W
Worldwide Clinical Trials
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 standard therapy or for which no standard therapy exists
- Presence of measurable disease according to RECIST version 1.1 except for Part A (Dose Escalation)
- Adequate bone marrow, end-organ, and cardiovascular function
- Resolution of all acute or toxic effects of prior therapies, radiation, or surgery to Grade 1 (except fatigue, hair loss, and peripheral neuropathy)
You will not qualify if you...
- Clinically significant cardiovascular disease
- Known WRN syndrome
- Pregnancy, breastfeeding, or intention of becoming pregnant during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
Actively Recruiting
2
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
3
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
4
Cayuga Cancer Center
Ithaca, New York, United States, 14850
Terminated
5
Levine Cancer Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
6
Atrium Health Wake Forest Baptist Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
7
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
8
Brown University Health
Providence, Rhode Island, United States, 02901
Actively Recruiting
9
Prisma Health Cancer Institute - Multidisciplinary Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
10
University of Virginia Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
11
Virginia Cancer Specialists, P.C. - Fairfax
Fairfax, Virginia, United States, 22031
Actively Recruiting
12
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
13
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
14
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G2C4
Actively Recruiting
15
Hôpital Saint-Antoine - Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, France, 75012
Actively Recruiting
16
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, France, 86021
Actively Recruiting
17
START Dublin
Dublin, Ireland, D07 R2WY
Actively Recruiting
18
START Lisbon
Lisbon, Portugal, 1649-028
Actively Recruiting
19
START Barcelona
Barcelona, Spain, 08023
Actively Recruiting
20
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
21
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD
Actively Recruiting
22
The Christie NHS Foundation Trust UK
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
S
Sean Rossi
CONTACT
K
Katie Ard, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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