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

NCT06679582 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: REFRαME P12023-506240-16-00
• Study Type: interventional
• Target: 24
• Locations: 9 countries
• Sites: 36

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.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

CBFA2T3::GLIS2 Fusion; CBFA2T3::GLIS2 AML; RAM Phenotype (CD56pos); CD45, CD38, HLA-DR weak or absent); REFRaME; AML, Child; Pediatric AML; REFRaME-P1; Luveltamab; tazevibulin; STRO-002

Outcome Measures

Primary Outcomes (1)

• Evaluate efficacy of luveltamab tazevibulin monotherapy

  Complete remission rate

  Up to 12 weeks

Secondary Outcomes (8)

• Assess additional efficacy outcome measures

  Up to 2 years

• Evaluate safety measures

  Up to 2 years

• To characterize the PK of luveltamab tazevibulin

  Up to 2 years

• Assess the immunogenic potential of luveltamab tazevibulin

  Up to 2 years

• Assess additional efficacy outcome measures

  Up to 2 years

Study Arms (2)

Cohort 1

EXPERIMENTAL

Luveltamab tazevibulin 3.5mg every 2 weeks

Drug: Luveltamab tazevibulin

Cohort 2

EXPERIMENTAL

Luveltamab tazevibulin 4.3 mg every 2 weeks

Drug: Luveltamab tazevibulin

Interventions

Luveltamab tazevibulin 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

Also known as: STRO-002, Luvelta

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 1 Day - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sutro Biopharma, Inc.: lead
• Children's Oncology Group: collaborator
• Innovative Therapies For Children with Cancer Consortium: collaborator

Study Sites (36)

Childrens Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Childrens Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Lucile Packard Childrens Hospital-Stanford

Palo Alto, California, 94304, United States

Location

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

Childrens National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Children's Hospital of Atlanta-Emory

Atlanta, Georgia, 30322, United States

Location

Ann & Robert H. Lurie Childrens Hospital

Chicago, Illinois, 60611, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Minnesota-Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Washington University-School of Medicine

St Louis, Missouri, 63110, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27711, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine-Dan Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Massey Cancer Center-Adult Outpatient Pavillion

Richmond, Virginia, 23219, United States

Location

Seattle Childrens

Seattle, Washington, 98105, United States

Location

St Anna Kinderspital

Vienna, 1090, Austria

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Centre Hospitalier Universitaire-Sainte Justice

Montreal, Quebec, H3T 1C5, Canada

Location

Rigshopitalet-University of Copenhagen

Copenhagen, 02100, Denmark

Location

Institut d'hématologie et d'oncologie pédiatrique

Lyon, 69008, France

Location

Hopital Armand Trousseau

Paris, 75012, France

Location

Charite-Universitatsmedizin Berlin

Berlin, 13353, Germany

Location

Universitatsklinikum-Essen

Essen, 45122, Germany

Location

Fondazione IRCCS San Gerardo dei Tintori

Monza, 20900, Italy

Location

Children Hospital Bambino Gesu IRCCS

Rome, 00165, Italy

Location

Princess Maxima Center for Pediatric Oncology

CS Utrecht, 3584, Netherlands

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Infantil Universitario Nino Jesus-Servicio de Hematologia

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Craig Berman, MD

  Sutro Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 7, 2024
• Study Start: December 4, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); ES (2); IT (2); DK (1); AU (1); US (23); CA (2); DE (2); FR (2)