Luveltamab Tazevibulin for Myeloid Leukemia

Recruiting at 4 trial locations

Overseen By Anna Butturini, MD

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sutro Biopharma, Inc.

Must not be taking: FOLR1 ADCs, Tubulin inhibitors

Disqualifiers: CNS disease, Corneal disorders, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

24 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does exclude those who have had certain treatments recently, so it's best to discuss your specific medications with the trial team.

What is the purpose of this trial?

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.

Research Team

Craig Berman, MD

Principal Investigator

Sutro Biopharma

Eligibility Criteria

This trial is for infants and children under 12 with a rare form of Acute Myeloid Leukemia (AML) that didn't improve or came back after treatment. They must have a specific genetic change in their leukemia cells, be able to do some activities on their own, and have organs working well.

Inclusion Criteria

My organs are functioning well.

My AML is confirmed to have the CBFA2T3-GLIS2 gene fusion.

I can do most activities but need help with some.

Exclusion Criteria

I have an active brain or spinal cord disease.

I have GVHD or am being treated for it, but only with low dose steroids.

I have been treated with a specific type of targeted cancer drug before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive luveltamab tazevibulin in two dose cohorts, with IV administration every 2 weeks as monotherapy or every 4 weeks with chemotherapy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including complete remission rate and safety measures

Up to 2 years

Treatment Details

Interventions

• Luveltamab Tazevibulin

Trial Overview The trial tests Luveltamab tazevibulin, an experimental drug designed to target and kill leukemia cells with the CBFA2T3::GLIS2 gene fusion. It's an antibody-drug conjugate which means it delivers cancer-fighting medicine directly to the affected cells.

Participant Groups

Group I: Cohort 2 Experimental Treatment 1 Intervention

Luveltamab tazevibulin 4.3 mg every 2 weeks

Group II: Cohort 1 Experimental Treatment 1 Intervention

Luveltamab tazevibulin 3.5mg every 2 weeks

Who Is Running the Clinical Trial?

Sutro Biopharma, Inc.

Lead Sponsor

Trials

7

Recruited

1,100+

Innovative Therapies For Children with Cancer Consortium

Collaborator

Trials

14

Recruited

2,100+

Children's Oncology Group (COG)

Collaborator

Trials

3

Recruited

380+

Children's Oncology Group

Collaborator

Trials

467

Recruited

241,000+