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)

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.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 evaluate the safety and the efficacy of the selected dose. Subjects who achieve complete remission atter two cycles of treatment may continue Luveltamab tazevibulin as monotherapy, while non-responders at

Trial Eligibility

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

Study Info

Interventions

Locations Recruiting

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