Clinical Research Directory
Browse clinical research sites, groups, and studies.
Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML
Sponsor: Sutro Biopharma, Inc.
Summary
This trial will evaluate whether luveltamab tazevibulin is well tolerated and active against a rare form of AML carrying a particular genetic abnormality called CBFA2T3::GLIS2 that arises in infants and children. To be treated in this trial children must have a leukemia which did not respond or recurred after prior treatment. Luveltamab tazevibulin is an antibody-drug conjugate, which brings tazevibulin, an anticancer drug, to a molecule called FOLR1, present on the surface of CBFA2T3::GLIS2 AML cells.
Official title: A Phase 1/2, Open-label Study Evaluating the Efficacy, Safety, and Pharmacokinetics (PK) of Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With CBFA2T3::GLIS2 Acute Myeloid Leukemia (AML)
Key Details
Gender
All
Age Range
1 Day - 12 Years
Study Type
INTERVENTIONAL
Enrollment
1
Start Date
2024-12-04
Completion Date
2025-01-21
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Luveltamab tazevibulin
Luveltamab tazevibulin is an antibody-drug conjugate (ADC) targeting folate receptor α (FRα or FOLR1). It consists of an IgG1 antibody (SP8166) conjugated to cathepsin cleavable 3-aminophenyl hemiasterlin payload, yielding a homogenous ADC with a drug antibody ratio of four. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death. Other Names: * STRO-002 * Luvelta
Locations (36)
Childrens Hospital of Alabama
Birmingham, Alabama, United States
Childrens Hospital of Los Angeles
Los Angeles, California, United States
Lucile Packard Childrens Hospital-Stanford
Palo Alto, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Childrens National Hospital
Washington D.C., District of Columbia, United States
Children's Hospital of Atlanta-Emory
Atlanta, Georgia, United States
Ann & Robert H. Lurie Childrens Hospital
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota-Masonic Cancer Center
Minneapolis, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University-School of Medicine
St Louis, Missouri, United States
Columbia University Irving Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine-Dan Duncan Comprehensive Cancer Center
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Massey Cancer Center-Adult Outpatient Pavillion
Richmond, Virginia, United States
Seattle Childrens
Seattle, Washington, United States
St Anna Kinderspital
Vienna, Austria
The Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire-Sainte Justice
Montreal, Quebec, Canada
Rigshopitalet-University of Copenhagen
Copenhagen, Denmark
Institut d'hématologie et d'oncologie pédiatrique
Lyon, France
Hopital Armand Trousseau
Paris, France
Charite-Universitatsmedizin Berlin
Berlin, Germany
Universitatsklinikum-Essen
Essen, Germany
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Children Hospital Bambino Gesu IRCCS
Rome, Italy
Princess Maxima Center for Pediatric Oncology
CS Utrecht, Netherlands
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Infantil Universitario Nino Jesus-Servicio de Hematologia
Madrid, Spain