Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age with Relapsed/Refractory CBFA2T3::GLIS2 AML
- Registration Number
- NCT06679582
- Lead Sponsor
- Sutro Biopharma, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 Luveltamab tazevibulin Luveltamab tazevibulin 3.5mg every 2 weeks Cohort 2 Luveltamab tazevibulin Luveltamab tazevibulin 4.3 mg every 2 weeks
- Primary Outcome Measures
Name Time Method Evaluate efficacy of luveltamab tazevibulin monotherapy Up to 12 weeks Complete remission rate
- Secondary Outcome Measures
Name Time Method Assess additional efficacy outcome measures Up to 2 years • Overall survival (OS)
Evaluate safety measures Up to 2 years Incidence and severity of AEs and clinical laboratory abnormalities per NCI CTCAE v5.0 in patients receiving luveltamab tazevibulin monotherapy.
To characterize the PK of luveltamab tazevibulin Up to 2 years Concentration of luveltamab tazevibulin (ADC, TAb, and SC209) in the blood.
Assess the immunogenic potential of luveltamab tazevibulin Up to 2 years Incidence of ADAs
Trial Locations
- Locations (4)
Childrens Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
Childrens National Hospital
🇺🇸Washington, District of Columbia, United States
Children's Hospital of Philadelphia (CHOP)
🇺🇸Philadelphia, Pennsylvania, United States
VCU Massey Cancer Center-Adult Outpatient Pavillion
🇺🇸Richmond, Virginia, United States