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Purpose

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

Eligibility

Eligible Ages
Between 1 Day and 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This trial has two parts, Part 1 will use a parallel model by assessing two luveltamab tazevibulin doses (3.5 and 4.3 mg/kg every 2 weeks). Two cohorts will be run in parallel. The transition from part 1 to part 2 is sequential, with part 2 testing the dose selected at the end of part 1.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 		Luveltamab tazevibulin 3.5mg every 2 weeks
  • Drug: Luveltamab tazevibulin
    Luveltamab tazevibulin is an antibody-drug conjugate (ADC) targeting folate receptor α (FRα or FOLR1). It consists of an IgG1 antibody (SP8166) conjugated to cleavable 3-3-aminophenyl hemiasterlin drug-linkers at 4 sites. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death. Other Names: - STRO-002 - Luvelta
    Other names:
    • STRO-002
    • Luvelta
Experimental
Cohort 2 		Luveltamab tazevibulin 4.3 mg every 2 weeks
  • Drug: Luveltamab tazevibulin
    Luveltamab tazevibulin is an antibody-drug conjugate (ADC) targeting folate receptor α (FRα or FOLR1). It consists of an IgG1 antibody (SP8166) conjugated to cleavable 3-3-aminophenyl hemiasterlin drug-linkers at 4 sites. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death. Other Names: - STRO-002 - Luvelta
    Other names:
    • STRO-002
    • Luvelta

Recruiting Locations

Childrens Hospital of Alabama
Birmingham, Alabama 35233
Contact:
Bridget Tate, Study Coordinator
205-638-9285
pedsCTO@uabmc.edu

More Details

Status
Recruiting
Sponsor
Sutro Biopharma, Inc.

Study Contact

Anna Butturini, MD
650-881-6581
CBFGLISAML@sutrobio.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.