A Phase 1b/2 Open-Label Study of APVO436 in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Aptevo Therapeutics
Summary
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.
Description
Phase 1b consists of 28-day cycles of treatment in five sequential cohorts. In Cycle 1 (C1) only, to reduce the risk of CRS, each cohort will receive 4 priming doses of APVO436 respectively. APVO436 will be given in combination with venetoclax and azacitidine. For C1D15 and all doses in each subsequent cycle, cohorts will receive APVO436 at the determined cohort dose level. APVO436 dosing will be administered by a 4-hour intravenous (IV) infusion.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 1\. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World Health Organization (WHO) criteria and not been previously treated. 3\. Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry \[IHC\]). Confirmation at diagnosis is acceptable. 4\. Patient must be considered ineligible for induction therapy defined by at least one of the following: 1. ≥75 years of age 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3 3. Cardiac disorder (e.g., congestive heart failure requiring…
Interventions
- DrugAPVO436
Infusion drug administered as a 4 hour infusion.
- DrugVenetoclax
Oral tablet given on days 1 through 22, of a 28 day cycle.
- DrugAzacitidine
Intravenous infusion given on days 1-8 of a 28 day cycle
Locations (7)
- Colorado Blood Cancer InstituteDenver, Colorado
- University of MiamiMiami, Florida
- University of KansasFairway, Kansas
- Gabrail Cancer CenterCanton, Ohio
- Oncology Hematology CareCincinnati, Ohio
- University of Texas Southwestern Medical CenterDallas, Texas