APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML

Part of paid clinical trials in Denver, Colorado.

Sponsor
Aptevo Therapeutics
Study ID
NCT06634394
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • APVO436 — DRUG
    Infusion drug administered as a 4 hour infusion.
  • Venetoclax — DRUG
    Oral tablet given on days 1 through 22, of a 28 day cycle.
  • Azacitidine — DRUG
    Intravenous infusion given on days 1-8 of a 28 day cycle

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Oct 2024
Primary completion
Oct 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm APVO436 in combination with Venetoclax and Azacitidine
    APVO436 at escalating dose levels in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.

Primary Outcome Measure

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 [ Time Frame: Through the end study completion average of 1 year. ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer InstituteDenverColorado80218
Research Coordinator
[email protected]
University of MiamiMiamiFlorida33124
Research Coordinator
[email protected]
University of KansasFairwayKansas66205
Research Coordinator
[email protected]
Gabrail Cancer CenterCantonOhio44718
Reserach Coordinator
[email protected]
Oncology Hematology CareCincinnatiOhio45226
Research Coordinator
[email protected]
University of Texas Southwestern Medical CenterDallasTexas75390
Research Coordinator
[email protected]
MD Anderson Cancer CenterHoustonTexas77030
Research Coordinator
[email protected]

Find similar trials in Denver, CO

By research site
Colorado Blood Cancer Institute· Denver, COUniversity of Miami· Miami, FLUniversity of Kansas· Fairway, KSGabrail Cancer Center· Canton, OHOncology Hematology Care· Cincinnati, OHUniversity of Texas Southwestern Medical Center· Dallas, TX

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