APVO436 + Venetoclax + Azacitidine for AML

Recruiting at 6 trial locations

Overseen By Caroline Taromino

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Aptevo Therapeutics

Must be taking: Venetoclax, Azacitidine

Must not be taking: Hypomethylating agents, Chemotherapy

Disqualifiers: Autoimmune disorders, CNS involvement, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28-day cycles

39 Participants Needed

Trial Summary

What is the purpose of this trial?

A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.

Research Team

Dirk Huebner, MD

Principal Investigator

Aptevo Therapeutics

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed, CD123+ Acute Myeloid Leukemia (AML) who haven't been treated before. They should be able to perform daily activities with some limitations (ECOG status 2 or 3), have a life expectancy of at least 12 weeks, and their major organs must function within certain limits.

Inclusion Criteria

6. Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN 5. Patient must have a projected life expectancy of ≥12 weeks

I am 18 or older with confirmed AML and have not received treatment for it.

I have limited self-care abilities and spend more than half of my waking hours in bed or a chair.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive APVO436 in combination with venetoclax and azacitidine in 28-day cycles, with dose escalation across five cohorts

28-day cycles

Multiple visits per cycle for IV infusion

Follow-up

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

Up to 1 year

Treatment Details

Interventions

• APVO436

Trial Overview The study tests different doses of APVO436 combined with venetoclax and azacitidine in patients. It's an open-label trial, meaning everyone knows what treatment they're getting, and it aims to find the best dose level for this combination therapy.

Participant Groups

Group I: Treatment Arm APVO436 in combination with Venetoclax and Azacitidine Experimental Treatment 3 Interventions

APVO436 at escalating dose levels in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.

Who Is Running the Clinical Trial?

Aptevo Therapeutics

Lead Sponsor

Trials

9

Recruited

490+