Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML

Stopped early · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

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.

Key facts

Study ID

NCT06679582

Run by

Sutro Biopharma, Inc.

People needed

24

Starts

2024-12-04

Expected to finish

2025-06-01

Last updated by the study team

2025-08-24

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• AML with CBFA2T3::GLIS2 gene fusion centrally confirmed
• Refractory or relapsed disease with ≥ 5% bone marrow involvement with leukemic blasts by morphology
• Age < 12 years.
• Lansky performance of ≥ 50
• Adequate organ functions

You may not qualify if…

• Active central nervous system (CNS) disease (CNS3)
• Pre-existing clinically significant corneal disorders or constitutional diseases associated with an increased risk of AML treatment toxicities
• Active or uncontrolled infections or other active severe intercurrent illnesses,
• Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
• History of allogeneic hematopoietic stem cell transplant or any organ transplant in the prior 84 days
• Graft versus host disease (GVHD) of any grade or GVHD treatment with exception of low dose steroids

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.