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A Study of NDI 1150-101 in Patients With Solid Tumors
Sponsor: Nimbus Saturn, Inc.
Summary
This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adult patients with advanced solid tumors.
Official title: A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination With Pembrolizumab in Patients With Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2021-11-05
Completion Date
2025-05
Last Updated
2024-11-25
Healthy Volunteers
No
Conditions
Interventions
NDI-101150
NDI-101150 capsules
Pembrolizumab
Pembrolizumab IV infusion
Locations (19)
Honor Health Research Institute
Scottsdale, Arizona, United States
Yale Cancer Center
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Ocala Oncology Center
Ocala, Florida, United States
Norton Cancer Institute
Louisville, Kentucky, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Henry Ford Cancer
Detroit, Michigan, United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, United States
Washington University
St Louis, Missouri, United States
Hackensack University
Hackensack, New Jersey, United States
Columbia University Irving Medical Center
New York, New York, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Center for Oncology and Blood Disorders
Houston, Texas, United States
Oncology Consultants
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States
Northwest Medical Specialties
Tacoma, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States