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

Sponsor: Sutro Biopharma, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06679582

This Phase 1/2 trial assesses luveltamab tazevibulin, an antibody-drug conjugate targeting FOLR1, in children under 12 with relapsed/refractory CBFA2T3::GLIS2 AML. Participants must have confirmed gene fusion, ≥5% bone marrow leukemic blasts, and adequate organ function. The trial evaluates safety and efficacy, with dosing every 2 weeks as monotherapy or every 4 weeks with chemotherapy.

Patient Parameters

Program 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.

Description

This is a registrational international, multicenter, two-part open label Phase 1/2 trial in an extremely rare pediatric disease (around 17 new patients a year in US and 10 in EU). Part 1 randomizes subjects 1:1 to one of two luveltamab tazevibulin dose cohorts (1a and 1b). Part 2 further evaluates the safety and the efficacy of the selected dose. Subjects who achieve complete remission after two cycles of treatment may continue luveltamab tazevibulin as monotherapy, while non-responders at PI discretion may add luveltamab tazevibulin with stadard of care (SOC) AML treatments. Luveltamab tazevibulin is given IV every two week as monotherapy and every 4 weeks when given with chemotherapy.

Eligibility Criteria

Inclusion 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

Exclusion Criteria

  • 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

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