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

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.

Conditions

Acute Myeloid Leukemia (AML)

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Acute Myeloid Leukemia (AML)
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

1 Day to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sutro Biopharma, Inc.,

Craig Berman, MD, STUDY_DIRECTOR, Sutro Biopharma

Study Record Dates

2029-03