Status:
RECRUITING
A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
Lead Sponsor:
Nimbus Wadjet, Inc.
Collaborating Sponsors:
Worldwide Clinical Trials
Conditions:
Advanced Solid Tumors Cancer
MSI-H Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief 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 qu...
Detailed Description
Study 9216-101 is a first-in-human (FIH), Phase 1/2, open-label, dose escalation, dose optimization, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynam...
Eligibility Criteria
Inclusion
- 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
- Clinically significant cardiovascular disease.
- Patients with known WRN syndrome.
- Pregnancy, breastfeeding, or intention of becoming pregnant during the study.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06898450
Start Date
March 31 2025
End Date
December 1 2031
Last Update
November 18 2025
Active Locations (18)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
2
Life Clinical Trials
Coral Springs, Florida, United States, 33065
3
University of Chicago Medicine
Chicago, Illinois, United States, 60637
4
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202