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

Sutro Biopharma

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Drug: Luveltamab tazevibulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06679582

2023-506240-16-00 (EU Trial (CTIS) Number)

REFRαME P1

Details and patient eligibility

About

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.

Full 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 evaluate the safety and the efficacy of the selected dose. Subjects who achieve complete remission atter two cycles of treatment may continue Luveltamab tazevibulin as monotherapy, while non-responders at PI discretion may add luveltamab tazevibulin to conventional AML treatments. Luveltamab tazevibulin is given IV every two week as monotherapy and every 4 weeks when given with chemotherapy.

Enrollment: 24 estimated patients

Sex: All

Ages: 1 day to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Luveltamab tazevibulin 3.5mg every 2 weeks

Treatment:

Drug: Luveltamab tazevibulin

Cohort 2

Experimental group

Description:

Luveltamab tazevibulin 4.3 mg every 2 weeks

Treatment:

Drug: Luveltamab tazevibulin