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NCT06679582 | RECRUITING | Acute Myeloid Leukemia (AML)

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

Sutro Bioforma, this.

Brief 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.

Condition or disease

Acute Myeloid Leukemia (AML)

Intervention/treatment

Luveltamab tazevibulin

Phase

PHASE1

PHASE2

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-12-04
Estimated Primary Completion Date : 2028-12
Estimated Study Completion Date : 2029-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Day to 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age with Relapsed/Refractory CBFA2T3::GLIS2 AML

Location Details

NCT06679582

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Locations

RECRUITING

United States, Albama

Childrens Hospital of Alabama

Birmingham, Albama, United States, 35233

RECRUITING

United States, District of Columbia

Childrens National Hospital

Washington, District of Columbia, United States, 20010

RECRUITING

United States, Pennsylvania

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Virginia

VCU Massey Cancer Center-Adult Outpatient Pavillion

Richmond, Virginia, United States, 23219