Acute Myeloid Leukemia (AML)Phase 1/2NCT06679582
Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML
A Phase 1/2 study testing Luveltamab tazevibulin in people with Acute Myeloid Leukemia (AML), run by Sutro Biopharma, Inc. at 36 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 12 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Luveltamab tazevibulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 36 sitesin 9 countries
- Study dates
- 4 Dec 2024to 21 Jan 2025
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
36 sites in 9 countries.
36 sites in 9 countries
United States23 sites
Children's Hospital of Atlanta-Emory
Atlanta, Georgia, 30322
Children's Hospital of Colorado
Aurora, Colorado, 80045
Childrens Hospital of Alabama
Birmingham, Alabama, 35233
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Ann & Robert H. Lurie Childrens Hospital
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Duke University Medical Center
Durham, North Carolina, 27711
Cook Children's Medical Center
Fort Worth, Texas, 76104
Baylor College of Medicine-Dan Duncan Comprehensive Cancer Center
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
Children's Mercy Hospital
Kansas City, Missouri, 64108
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Minnesota-Masonic Cancer Center
Minneapolis, Minnesota, 55455
Columbia University Irving Medical Center
New York, New York, 10032
Lucile Packard Childrens Hospital-Stanford
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Massey Cancer Center-Adult Outpatient Pavillion
Richmond, Virginia, 23219
Seattle Childrens
Seattle, Washington, 98105
Washington University-School of Medicine
St Louis, Missouri, 63110
Childrens National Hospital
Washington D.C., District of Columbia, 20010
Canada2 sites
Centre Hospitalier Universitaire-Sainte Justice
Montreal, Quebec, H3T 1C5
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
France2 sites
Institut d'hématologie et d'oncologie pédiatrique
Lyon, 69008
Hopital Armand Trousseau
Paris, 75012
Germany2 sites
Charite-Universitatsmedizin Berlin
Berlin, 13353
Universitatsklinikum-Essen
Essen, 45122
Italy2 sites
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
Children Hospital Bambino Gesu IRCCS
Rome, 00165
Spain2 sites
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Infantil Universitario Nino Jesus-Servicio de Hematologia
Madrid, 28009
Netherlands1 site
Princess Maxima Center for Pediatric Oncology
CS Utrecht, 3584
About this study
Official title: A Phase 1/2, Open-label Study Evaluating the Efficacy, Safety, and Pharmacokinetics (PK) of Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With CBFA2T3::GLIS2 Acute Myeloid Leukemia (AML)
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.
Read the 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)
- Being tested
- Luveltamab tazevibulin
- 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
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luveltamab tazevibulinDrug
Also called STRO-002, Luvelta
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Luveltamab tazevibulin 3.5mg every 2 weeks Receives: Drug: Luveltamab tazevibulin |
| Cohort 2 | Experimental | Luveltamab tazevibulin 4.3 mg every 2 weeks Receives: Drug: Luveltamab tazevibulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Efficacy of Luveltamab Tazevibulin Monotherapy
Complete remission rate
Measured: Up to 12 weeks
Secondary outcomes (8)
Evaluate Safety Measures
Incidence and severity of AEs and clinical laboratory abnormalities per NCI CTCAE v5.0 in patients receiving luveltamab tazevibulin monotherapy.
Measured: Up to 2 years
To Characterize the PK of Luveltamab Tazevibulin
Concentration of luveltamab tazevibulin (ADC, TAb, and SC209) in the blood.
Measured: Up to 2 years
Assess the Immunogenic Potential of Luveltamab Tazevibulin
Incidence of ADAs
Measured: Up to 2 years
Assess Additional Efficacy Outcome Measures
- Response rate including complete remission with partial hematologic recovery (CRh) rate [CR = CRh]
Measured: Up to 2 years
Assess Additional Efficacy Outcome Measures
- Event-free survival (EFS)
Measured: Up to 2 years
Assess Additional Efficacy Outcome Measures
- Relapse-free survival (RFS)
Measured: Up to 2 years
Assess Additional Efficacy Outcome Measures
- Overall survival (OS)
Measured: Up to 2 years
Assess Additional Efficacy Outcome Measures
Duration of CR
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start4 Dec 2024
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Why it stopped: Terminated Early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sutro Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Oncology Group, Innovative Therapies For Children with Cancer Consortium
- Responsible party
- Sponsor
- Investigators
- Craig Berman, MD, Study director, Sutro Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679582
- Sponsor's protocol ID
- REFRαME P1
- Other IDs
- 2023-506240-16-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2024
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No