Cusatuzumab + Background Therapy for Acute Myeloid Leukemia
(ELEVATE Trial)

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: OncoVerity, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).

Eligibility Criteria

This trial is for adults with a new or secondary type of acute myeloid leukemia (AML) who haven't been treated yet, except to manage high white blood cell counts. They should be fairly active and not eligible for intensive chemo or stem cell transplant at the start. People with HIV, central nervous system leukemia, allergies to the drugs being tested, or recent live vaccines can't join.

Inclusion Criteria

I cannot undergo intensive chemotherapy.

My condition is acute myeloid leukemia (AML), either newly diagnosed or after a previous cancer.

I have been diagnosed with acute myeloid leukemia, not including acute promyelocytic leukemia.

See 3 more

Exclusion Criteria

I am eligible for a stem cell transplant from a donor.

I am HIV positive.

My leukemia has spread to my brain or spinal cord.

See 2 more

Treatment Details

Interventions

Azacitidine (Anti-metabolites)
Cusatuzumab (Monoclonal Antibodies)
Venetoclax (Anti-tumor antibiotic)

Trial OverviewThe study tests cusatuzumab combined with other AML treatments like venetoclax and azacitidine. It aims to understand how safe this combination is and how well patients tolerate it.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Experimental: Cohort 2: Cusatuzumab + VenetoclaxExperimental Treatment2 Interventions

Participants enrolled in this cohort will receive venetoclax ramp-up to 400 mg orally (as background therapy) starting on Cycle 1 Day 1 and followed by 400 mg daily dosing starting on Cycle 1 Day 4 plus cusatuzumab IV on Day 3 and Day 17 of each 28-day cycle. Cohort 2 will not be enrolled in the US.

Group II: Cohort 3: Cusatuzumab + Venetoclax + Azacitidine (CVA)Experimental Treatment3 Interventions

Participants enrolled at US sites will receive cusatuzumab 10 mg/kg and potentially escalate to 20 mg/kg IV in combination with azacitidine 75 mg/m\^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies). Participants enrolled from ex-US sites will receive cusatuzumab 20 mg/kg and potentially de-escalate to 10 mg/kg IV in combination with azacitidine 75 mg/m\^2 SC or IV plus venetoclax ramp-up to 400 mg orally (as background therapies).

Azacitidine is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Vidaza for: