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

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

  • Acute Myeloid Leukemia (AML)

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.