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

NCT ID: NCT06679582

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-04
• Study Completion Date: 2025-06-01

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 standard of care (SOC) AML treatments. Luveltamab tazevibulin is given IV every two week as monotherapy and every 4 weeks when given with chemotherapy.

Conditions

Acute Myeloid Leukemia (AML)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Luveltamab tazevibulin 3.5mg every 2 weeks

Group Type: EXPERIMENTAL

Luveltamab tazevibulin

Intervention Type: DRUG

Luveltamab tazevibulin is an antibody-drug conjugate (ADC) targeting folate receptor α (FRα or FOLR1). It consists of an IgG1 antibody (SP8166) conjugated to cathepsin cleavable 3-aminophenyl hemiasterlin payload, yielding a homogenous ADC with a drug antibody ratio of four. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death.

Other Names:

• STRO-002
• Luvelta

Cohort 2

Luveltamab tazevibulin 4.3 mg every 2 weeks

Group Type: EXPERIMENTAL

Luveltamab tazevibulin

Intervention Type: DRUG

Luveltamab tazevibulin is an antibody-drug conjugate (ADC) targeting folate receptor α (FRα or FOLR1). It consists of an IgG1 antibody (SP8166) conjugated to cathepsin cleavable 3-aminophenyl hemiasterlin payload, yielding a homogenous ADC with a drug antibody ratio of four. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death.

Other Names:

• STRO-002
• Luvelta

Interventions

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 cathepsin cleavable 3-aminophenyl hemiasterlin payload, yielding a homogenous ADC with a drug antibody ratio of four. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death.

Other Names:

• STRO-002
• Luvelta

Intervention Type: DRUG

Other Intervention Names

STRO-002; Luvelta

Eligibility 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Oncology Group

NETWORK

Sponsor Role: collaborator

Innovative Therapies For Children with Cancer Consortium

OTHER

Sponsor Role: collaborator

Sutro Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Berman, MD

Role: STUDY_DIRECTOR

Sutro Biopharma

Locations

Childrens Hospital of Alabama

Birmingham, Alabama, United States

Childrens Hospital of Los Angeles

Los Angeles, California, United States

Lucile Packard Childrens Hospital-Stanford

Palo Alto, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

Childrens National Hospital

Washington D.C., District of Columbia, United States

Children's Hospital of Atlanta-Emory

Atlanta, Georgia, United States

Ann & Robert H. Lurie Childrens Hospital

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Minnesota-Masonic Cancer Center

Minneapolis, Minnesota, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Washington University-School of Medicine

St Louis, Missouri, United States

Columbia University Irving Medical Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Baylor College of Medicine-Dan Duncan Comprehensive Cancer Center

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Massey Cancer Center-Adult Outpatient Pavillion

Richmond, Virginia, United States

Seattle Childrens

Seattle, Washington, United States

St Anna Kinderspital

Vienna, , Austria

The Hospital for Sick Children

Toronto, Ontario, Canada

Centre Hospitalier Universitaire-Sainte Justice

Montreal, Quebec, Canada

Rigshopitalet-University of Copenhagen

Copenhagen, , Denmark

Institut d'hématologie et d'oncologie pédiatrique

Lyon, , France

Hopital Armand Trousseau

Paris, , France

Charite-Universitatsmedizin Berlin

Berlin, , Germany

Universitatsklinikum-Essen

Essen, , Germany

Fondazione IRCCS San Gerardo dei Tintori

Monza, , Italy

Children Hospital Bambino Gesu IRCCS

Rome, , Italy

Princess Maxima Center for Pediatric Oncology

CS Utrecht, , Netherlands

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital Infantil Universitario Nino Jesus-Servicio de Hematologia

Madrid, , Spain

Countries

United States; Austria; Canada; Denmark; France; Germany; Italy; Netherlands; Spain

Other Identifiers

2023-506240-16-00

Identifier Type: CTIS

Identifier Source: secondary_id

REFRαME P1

Identifier Type: -

Identifier Source: org_study_id