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New combo therapy for AML enters early human testing

NCT ID NCT04150887

Disease control Sponsor: OncoVerity, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a new drug called cusatuzumab alongside usual treatments for adults with acute myeloid leukemia (AML) who cannot have intensive chemotherapy. The main goal is to check the safety and side effects of the combination. About 61 participants will receive the drug, and researchers will also measure how the body processes it and whether it helps control the leukemia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

61 people

The number who actually took part.

Started

Dec 2019

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia, myeloid, acute

Contacts and locations

Locations

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • City of Hope

    Duarte, California, 91010, United States

  • INSELSPITAL, Universitätsspital Bern

    Bern, 3010, Switzerland

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776, Poland

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007, Switzerland

  • Klinikum der Universitaet Muenchen

    München, 81377, Germany

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14203, United States

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501, Poland

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

  • Universitaetsklinik Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Toronto

    Toronto, Ontario, M5G 2M9, Canada

  • University of Vermont

    Burlington, Vermont, 05401, United States

  • Weill Cornell Medicine

    New York, New York, 10021, United States

  • Wisconsin Medical Center

    Milwaukee, Wisconsin, 53226, United States

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    Lodz, 93-513, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.