Luveltamab Tazevibulin for Myeloid Leukemia

No longer recruiting at 38 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, luveltamab tazevibulin, for a rare type of acute myeloid leukemia (AML) in infants and children. The aim is to determine if this treatment is safe and effective for children whose leukemia did not respond to previous treatments or recurred. This drug targets cancer cells with a specific genetic glitch (CBFA2T3::GLIS2) and delivers a cancer-fighting agent directly to them. Children under 12 with this specific type of leukemia, unresponsive to other treatments, might be suitable candidates for this trial. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to access a potentially groundbreaking therapy early on.

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.

Is there any evidence suggesting that luveltamab tazevibulin is likely to be safe for humans?

Research has shown that luveltamab tazevibulin has been tested in patients with a type of leukemia similar to the one in this trial. In one study, 25 patients with hard-to-treat leukemia received doses of 4.3 or 5.2 mg/kg. The treatment was generally well-tolerated, with most patients not experiencing severe side effects. Common side effects included mild nausea and tiredness, which were manageable.

As this treatment is in early trials, researchers continue to study its safety. Its testing in humans suggests it demonstrated some safety in earlier stages. This treatment targets cancer cells specifically, potentially reducing harm to healthy cells. This targeted approach often minimizes severe side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for myeloid leukemia?

Unlike the standard treatments for myeloid leukemia, which typically involve chemotherapy and targeted therapies like FLT3 inhibitors, Luveltamab Tazevibulin offers a novel approach. This drug is unique because it specifically targets and disrupts the leukemia cells' microtubules. By interfering with the cell division process, Luveltamab Tazevibulin is designed to stop cancer cells from multiplying. Researchers are excited about this treatment because it has the potential to be more selective and less damaging to healthy cells, possibly leading to fewer side effects compared to traditional chemotherapy.

What evidence suggests that luveltamab tazevibulin might be an effective treatment for myeloid leukemia?

Initial studies suggest that luveltamab tazevibulin could be effective against certain types of acute myeloid leukemia (AML) with a specific genetic trait. In this trial, participants will receive either 3.5 mg or 4.3 mg of luveltamab tazevibulin every two weeks. Research has shown that this treatment might help more than one-third of patients with this genetic form of AML reach MRD negativity, a state where very few leukemia cells remain in the body. Achieving MRD negativity can make patients eligible for further treatments like transplants. Luveltamab tazevibulin delivers an anticancer drug directly to cancer cells with a specific marker, making it a promising treatment option. ^{1 4 6 7 8}

Who Is on the Research Team?

Craig Berman, MD

Principal Investigator

Sutro Biopharma

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06679582

NCT06679582 | Luveltamab Tazevibulin (STRO-002) in ... This trial will evaluate whether luveltamab tazevibulin is well tolerated and active against a rare form of AML carrying a particular genetic abnormality.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e22007

GLIS2 acute myeloid leukemia (AML). Luvelta alone or in combination with AML chemotherapy could achieve MRD negativity in more than one third of CBF/GLIS2 AML patients, allowing transplant and ...

3. sutrobio.com sutrobio.com/wp-content/uploads/2023/01/Sutro-STRO-002-Luvelta-update-Jan-9-2023-FINAL.pdf

Luveltamab Tazevibulin (Luvelta, STRO-002) Phase 1 ... Cohort C data are as of December 8, 2022. Potential to treat ~80% of patients with platinum- resistant ovarian cancer. Efficacy demonstrated by ...

4. sutrobio.com sutrobio.com/sutro-biopharma-announces-selected-dose-for-luvelta-and-topline-results-from-dose-optimization-portion-of-refr%CE%B1me-o1-trial-in-platinum-resistant-ovarian-cancer/

Sutro Biopharma Announces Selected Dose for Luvelta ... The topline results confirm luvelta's favorable safety and efficacy profile at the starting dose of 5.2 mg/kg, further supporting our confidence that it can ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-luveltamab-tazevibulin-stro-002-for-infants-and-children-under-12-with-acute-myeloid-leukemia-aml/

Study on the Safety and Effectiveness of Luveltamab ... This study examines the safety and effectiveness of Luveltamab Tazevibulin (STRO-002) in treating Acute Myeloid Leukemia (AML) in infants and children under ...

6. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/4295/502731/Anti-Leukemic-Activity-of-Luveltamab-Tazevibulin

Anti-Leukemic Activity of Luveltamab Tazevibulin (LT, STRO ... Results: Between August 2021 and March 2023, 25 pts with relapsed/refractory CBF-GLIS AML were treated with LT at doses of 4.3 or 5.2 mg/kg ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS10074

GLIS2 acute myeloid leukemia. | Journal of Clinical Oncology Preclinical studies have demonstrated that treatment with luvelta can result in leukemia clearance. Preliminary safety and efficacy data from 25 ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123108962

Anti-Leukemic Activity of Luveltamab Tazevibulin (LT ... LT, an investigational ADC, demonstrated potent in vitro and in vivo anti-leukemia activity in CBF-GLIS AML cell lines and xenograft models.