Cusatuzumab

DRUG7 trials

Sponsors

Oncoverity Inc., OncoVerity Inc., OncoVerity, Inc., Janssen Research & Development, LLC

Conditions

Acute Myeloid LeukemiaAcute myeloid leukemiaLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, ChronicMyelodysplastic Syndromes

Phase 1

Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia

Active, not recruitingNCT04150887

OncoVerity, Inc.Leukemia, Myeloid, Acute

Start: 2019-12-23End: 2027-05-15Updated: 2026-05-12

A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment

CompletedNCT04241549

OncoVerity, Inc.Leukemia, Myeloid, Acute

Start: 2020-03-25End: 2021-07-19Updated: 2023-08-09

Phase 2

A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

Active, not recruitingNCT04023526

OncoVerity, Inc.Leukemia, Myeloid, Acute

Start: 2019-07-29End: 2026-05-15Updated: 2025-08-20

A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

WithdrawnNCT04264806

Janssen Research & Development, LLCLeukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes

Start: 2021-05-06End: 2025-01-28Updated: 2022-05-20

A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

Active, not recruitingNCT06384261

OncoVerity, Inc.Leukemia, Myeloid, Acute

Start: 2024-07-22End: 2027-06-01Target: 140Updated: 2026-05-11

A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia who are not Candidates for Intensive Chemotherapy

Active, not recruitingCTIS2024-513283-26-00

OncoVerity Inc.Acute Myeloid Leukemia

Start: 2019-08-20Target: 1Updated: 2025-05-05

A multicenter, open-label, randomized, phase 2 study of venetoclax and azacitidine plus cusatuzumab versus venetoclax and azacitidine alone in newly diagnosed AML patients who are not candidates for intensive therapy

RecruitingCTIS2024-510991-19-00

Oncoverity Inc.Acute myeloid leukemia

Start: 2024-08-14Target: 29Updated: 2025-12-04

Related Papers

Cusatuzumab combined with venetoclax with or without azacitidine in unfit patients with newly diagnosed acute myeloid leukemia: phase Ib ELEVATE study.

2026-09-03

Trial in Progress: A Multicenter, Open Label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients Who Are Not Candidates for Intensive Therapy

Blood2024-11-05

Cusatuzumab plus azacitidine in newly diagnosed acute myeloid leukaemia ineligible for intensive chemotherapy (CULMINATE): part one of a randomised, phase 2, dose optimisation study.

2023-11-0110 citations

CULMINATE: A phase II study of cusatuzumab + azacitidine in patients with newly diagnosed AML, ineligible for intensive chemotherapy.

Journal of Clinical Oncology2020-05-2010 citations