Clinical trial NCT04150887: Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia
Official title: An Open-label, Multicenter, Phase 1b Study of OV-1001 (Cusatuzumab; Anti-CD70 Monoclonal Antibody) in Combination With Background Therapy for the Treatment of Subjects With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Leukemia, Myeloid, Acute
Lead sponsor: OncoVerity, Inc.
Sponsor class: INDUSTRY
Collaborators: name: argenx
name: Janssen Research & Development, LLC
First posted: 2019-11-05
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* Diagnosis of acute myeloid leukemia (AML) according to World Health Organization 2016 criteria . Participants with acute promyelocytic leukemia (APL) are not eligible
* Must be ineligible for intensive chemotherapy
* De novo or secondary AML
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Previously untreated AML except: emergency leukapheresis, hydroxyurea, and/or 1 dose 1-2 gram per meter square (g/m\^2) cytarabine during the Screening Phase to control hyperleukocytosis. These treatments must be discontinued greater than or equal to (\>=) 24 hours prior to start of study drug. Empiric all trans retinoic acid (ATRA) treatment for presumed acute promyelocytic leukemia (APL) is permitted but APL must be ruled out and ATRA must be discontinued \>=24 hours prior to the start of study drug
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

Exclusion Criteria:

* Leukemic involvement of the central nervous system
* Eligible for an allogeneic hematopoietic stem cell transplantation at study entry
* Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug
* A history of human immunodeficiency virus (HIV) antibody positive or tests positive for HIV if tested at screening
* Known allergies, hypersensitivity, or intolerance to cusatuzumab, venetoclax, azacitidine, or their excipients (example: mannitol, an excipient of azacitidine)

Primary outcomes:
measure: Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety
timeFrame: Up to 42 months
Secondary outcomes:
measure: Serum Concentration of Cusatuzumab
timeFrame: Up to 23 months
measure: Number of Participants with Anti-cusatuzumab Antibodies
timeFrame: Up to 23 months
measure: Percentage of Participants with Complete Response (CR)
timeFrame: Up to 42 months
measure: Percentage of Participants with Complete Remission with Partial Hematological Recovery (CRh)
timeFrame: Up to 42 months
measure: Percentage of Participants with CR with Incomplete Recovery (CRi)
timeFrame: Up to 42 months
measure: Percentage of Participants with CR plus CRh
timeFrame: Up to 42 months
measure: Overall Response Rate (ORR)
timeFrame: Up to 42 months
measure: Percentage of Participants with CR without MRD
timeFrame: Up to 42 months
measure: Percentage of Participants with Negative MRD who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS)
timeFrame: Up to 42 months
measure: Cohort 2 and 3: Time to Response
timeFrame: Up to 42 months
measure: Cohort 2 and 3: Duration of Response
timeFrame: Up to 42 months
measure: Cohort 2 and 3: Red Blood Cell (RBC) or Platelet Transfusion Independence
timeFrame: Up to 42 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Milwaukee
country: United States
facility: Wisconsin Medical Center
state: Wisconsin
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Hamburg
country: Germany
facility: Universitaetsklinik Hamburg-Eppendorf
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: München
country: Germany
facility: Klinikum der Universitaet Muenchen
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Bern
country: Switzerland
facility: INSELSPITAL, Universitätsspital Bern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
Study officials:
affiliation: OncoVerity, Inc.
name: Clayton Smith, MD
role: STUDY_DIRECTOR
References: