MedTrace Logo

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

NCT04150887 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-05-12

No results posted yet for this study

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).

Conditions

  • Leukemia, Myeloid, Acute

Interventions

DRUG

Cusatuzumab

Cusatuzumab will be administered as a dose of 10mg/kg or 20mg/kg intravenously.

DRUG

Azacitidine

Azacitidine will be administered 75 mg/m\^2 subcutaneously or intravenously.

DRUG

Venetoclax

Venetoclax will be administered orally and the dose will ramp-up to 400 mg.

Sponsors & Collaborators

  • argenx

    collaborator INDUSTRY

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • OncoVerity, Inc.

    lead INDUSTRY

Principal Investigators

  • Clayton Smith, MD · OncoVerity, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2027-05-15
Completion
2027-05-15
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Poland
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04150887 on ClinicalTrials.gov