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Brief Title: A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors
Official Title: A Phase 1/2 Study of NM21-1480 (Anti-PDL-1/Anti-4-1BB/Anti-HSA Tri-Specific Antibody) in Adult Patients With Advanced Solid Tumors
Study ID: NCT04442126
Brief Summary: This is a first-in-human, open-label, multi-center, Phase 1/2, dose-escalation study with expansion cohorts to evaluate NM21-1480 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCHealth Poudre Valley Hospital, Fort Collins, Colorado, United States
Augusta University Medical Center, Augusta, Georgia, United States
Tulane University Medical Center, New Orleans, Louisiana, United States
Henry Ford Health System, Detroit, Michigan, United States
St. Joseph Mercy Hospital, Ypsilanti, Michigan, United States
Dartmouth Cancer Center, Lebanon, New Hampshire, United States
Montefiore Medical Center, Bronx, New York, United States
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute), New York, New York, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC), Charleston, South Carolina, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
The University Of Texas MD Anderson Cancer Center, Houston, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Hospital Universitario de A Coruna, A Coruña, , Spain
Hospital Universitario Vall dHebron, Barcelona, , Spain
Hospital General Universitario de Elche, Elche, , Spain
Complejo Hospitalario de Jaen, Jaén, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
Clinica Universidad de Navarra - Madrid, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Hospital Universitario Son Llatzer, Palma De Mallorca, , Spain
Clinica Universidad de Navarra - Pamplona, Pamplona, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
National Taiwan University Hospital, Taipei, , Taiwan