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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Infusion drug administered as a 4 hour infusion.
Oral tablet given on days 1 through 22, of a 28 day cycle.
Intravenous infusion given on days 1-8 of a 28 day cycle
Colorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGUniversity of Kansas
Fairway, Kansas, United States
To assess the safety, tolerability, and maximum tolerated dose (MTD) of increasing doses of APVO436 in combination with venetoclax/azacitidine in patients with newly diagnosed AML
Incidence and severity of treatment emergent adverse events (TEAEs), including ≥Grade 3 adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs: ≥Grade 2 infusion related reaction (IRR), ≥Grade 2 cardiac toxicity, and ≥Grade 2 neurotoxicity as complication of cytokine release syndrome \[CRS\]).
Time frame: Through the end study completion average of 1 year.
Determine the efficacy of increasing doses of APVO436 in combination with venetoclax and azacitidine in patients with newly diagnosed AML
Complete remission (CR) rate
Time frame: Through the end study completion average of 1 year.
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Gabrail Cancer Center
Canton, Ohio, United States
RECRUITINGOncology Hematology Care
Cincinnati, Ohio, United States
RECRUITINGUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITING