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

Last updated: December 12, 2024
Sponsor: Sutro Biopharma, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Leukemia

Leukemia (Pediatric)

Treatment

Luveltamab tazevibulin

Clinical Study ID

NCT06679582
REFRαME P1
2023-506240-16-00
  • Ages 1-12
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • AML with CBFA2T3::GLIS2 gene fusion centrally confirmed

  • Refractory or relapsed disease with ≥ 5% bone marrow involvement with leukemicblasts by morphology

  • Age < 12 years.

  • Lansky performance of ≥ 50

  • Adequate organ functions

Exclusion

Exclusion Criteria:

  • Active central nervous system (CNS) disease (CNS3)

  • Pre-existing clinically significant corneal disorders or constitutional diseasesassociated 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 tubulininhibitor

  • History of allogeneic hematopoietic stem cell transplant or any organ transplant inthe prior 84 days

  • Graft versus host disease (GVHD) of any grade or GVHD treatment with exception oflow dose steroids

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Luveltamab tazevibulin
Phase: 1/2
Study Start date:
December 04, 2024
Estimated Completion Date:
March 31, 2029

Study 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.

Connect with a study center

  • Childrens Hospital of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Childrens National Hospital

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia (CHOP)

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • VCU Massey Cancer Center-Adult Outpatient Pavillion

    Richmond, Virginia 23219
    United States

    Active - Recruiting

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