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A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
Sponsor: Eli Lilly and Company
Summary
The purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.
Official title: A First-in-Human, Phase 1/2 Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
575
Start Date
2024-05-20
Completion Date
2029-06
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Sofe-M
Intravenous
bevacizumab
IV
carboplatin
IV
Itraconazole
oral
pembrolizumab
IV
Locations (25)
HonorHealth
Scottsdale, Arizona, United States
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States
Emory University
Atlanta, Georgia, United States
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States
NYU Langone Health - Long Island
Mineola, New York, United States
New York University (NYU) Clinical Cancer Center
New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
START Mountain Region
West Valley City, Utah, United States
Inova Schar Cancer Institute
Falls Church, Virginia, United States
Cancer Research SA
Adelaide, Australia
Icon Cancer Centre South Brisbane
QLD, Australia
Centre Leon Berard
Lyon, France
Institut de Cancerologie de l'Ouest - site St-Herblain
Saint-Herblain, France
Oncopole Claudius Regaud
Toulouse, France
Humanitas San Pio X
Milan, Italy
Istituto Europeo di Oncologia
Milan, Italy
Shizuoka Cancer Center
Shizuoka, Japan
National Cancer Center Hospital
Tokyo, Japan
Cancer Institute Hospital of JFCR
Tokyo, Japan
National Cancer Center
Goyang-si Gyeonggi-do, South Korea
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain