drugset / Trial / NCT06679582
Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML
Phase 1/2
Terminated
24 enrolled
Sutro Biopharma, Inc.
Children's Oncology Group · collabInnovative Therapies For Children with Cancer Consortium · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-12-04
- Primary completion
- 2025-06-01
- Completion
- 2025-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Luveltamab tazevibulin | Monoclonal antibody | 3.5 mg/kg | Intravenous |
| Subject | Luveltamab tazevibulin | Monoclonal antibody | 4.3 mg/kg | Intravenous |