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Brief Title: A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors
Official Title: A Phase 1b/2, Open-Label, Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab for Participants With Advanced Unresectable and/or Metastatic Immune Checkpoint Inhibitor (ICI) Refractory Solid Tumors or ICI Naïve MSS/MSI-Low Solid Tumors
Study ID: NCT05572684
Brief Summary: This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Oncology Associates, Tucson, Arizona, United States
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
St. Elizabeth Edgewood Hospital, Edgewood, Kentucky, United States
Ochsner Cancer Institute, New Orleans, Louisiana, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Hackensack Meridian Health University Medical Center- John Theurer Cancer Center, Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
NYU Langone Health, New York, New York, United States
University of Cincinnati Cancer Center, Cincinnati, Ohio, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
UT Health San Antonio, San Antonio, Texas, United States
Texas Oncology - San Antonio, San Antonio, Texas, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Virginia Cancer Specialist, Fairfax, Virginia, United States
Northwest Cancer Specialist, Vancouver, Washington, United States
Name: Han Myint, MD
Affiliation: NextCure, Inc.
Role: STUDY_DIRECTOR