TERMINATED

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

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Conditions

Acute Myeloid Leukemia (AML)CBFA2T3::GLIS2 FusionCBFA2T3::GLIS2 AMLRAM Phenotype (CD56pos); CD45, CD38, HLA-DR weak or absent)REFRaMEAML, ChildPediatric AMLREFRaME-P1LuveltamabtazevibulinSTRO-002

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-12-04
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06679582

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * AML with CBFA2T3::GLIS2 gene fusion centrally confirmed
  2. * Refractory or relapsed disease with ≥ 5% bone marrow involvement with leukemic blasts by morphology
  3. * Age \< 12 years.
  4. * Lansky performance of ≥ 50
  5. * Adequate organ functions
  1. * Active central nervous system (CNS) disease (CNS3)
  2. * Pre-existing clinically significant corneal disorders or constitutional diseases associated with an increased risk of AML treatment toxicities
  3. * Active or uncontrolled infections or other active severe intercurrent illnesses,
  4. * Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
  5. * History of allogeneic hematopoietic stem cell transplant or any organ transplant in the prior 84 days
  6. * Graft versus host disease (GVHD) of any grade or GVHD treatment with exception of low dose steroids

Contacts and Locations

Principal Investigator

Craig Berman, MD
STUDY_DIRECTOR
Sutro Biopharma

Study Locations (Sites)

Childrens Hospital of Alabama
Birmingham, Alabama, 35233
United States
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
United States
Lucile Packard Childrens Hospital-Stanford
Palo Alto, California, 94304
United States
Children's Hospital of Colorado
Aurora, Colorado, 80045
United States
Childrens National Hospital
Washington, District of Columbia, 20010
United States
Children's Hospital of Atlanta-Emory
Atlanta, Georgia, 30322
United States
Ann & Robert H. Lurie Childrens Hospital
Chicago, Illinois, 60611
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Minnesota-Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Washington University-School of Medicine
Saint Louis, Missouri, 63110
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Duke University Medical Center
Durham, North Carolina, 27711
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Baylor College of Medicine-Dan Duncan Comprehensive Cancer Center
Houston, Texas, 77030
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Massey Cancer Center-Adult Outpatient Pavillion
Richmond, Virginia, 23219
United States
Seattle Childrens
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Sutro Biopharma, Inc.

  • Craig Berman, MD, STUDY_DIRECTOR, Sutro Biopharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-04
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2024-12-04
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • CBFA2T3::GLIS2 Fusion
  • CBFA2T3::GLIS2 AML
  • RAM Phenotype (CD56pos); CD45, CD38, HLA-DR weak or absent)
  • REFRaME
  • AML, Child
  • Pediatric AML
  • REFRaME-P1
  • Luveltamab
  • tazevibulin
  • STRO-002

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia (AML)