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Study of APVO436 in Elderly or Unfit Patients With Newly Diagnosed AML

NCT04973618 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-12-01

No results posted yet for this study

Summary

The goal of this Phase IB study is to evaluate the safety and tolerability of APVO436 in naïve elderly unfit patients with newly diagnosed primary AML at the RP2D level when it is used as an adjunct to the standard of care and obtain a preliminary assessment of the anti-leukemia activity of an APVO436-containing combination therapy.

Study Objectives:

\- Primary Objective: Evaluate the safety and tolerability of APVO436 at the RP2D level when it is used as an adjunct to the standard of care (venetoclax and azacitidine).

\- Secondary Objectives:

* Obtain a preliminary assessment of the anti-leukemia activity of APVO436-containing experimental triple drug combination therapy modalities.
* Determine pharmacodynamics (PD) of APVO436, including changes in CD123 antigen density and measures of T cell number and function over time.
* Determine correlations between response and MRD level and cytogenetic and molecular genetic profiles.

Conditions

Interventions

BIOLOGICAL

APVO436

APVO436 Dosage: APVO436 will be administered at a fixed dosage of 18 mcg after a weekly ramp up during Cycle 1 (Step-up dosing: C1D15: 6 mcg over 22 hours, C1D22: 12 mcg over 8 hours, C2D1: 18 mcg over 6 hours, C2D8: 18 mcg over 4 hours), totaling 18 µg in Cycle 1 and 72 µg/cycle for Cycles 2-4 for a total of 234 µg for the projected 4-cycle treatment course. Dosage Form: IV Solutions for Intravenous Administration Frequency: Weekly

Sponsors & Collaborators

  • Aptevo Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-01-31
Completion
2027-01-31
FDA Drug
Yes

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Entities

Diseases

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 NCT04973618 on ClinicalTrials.gov