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Monoclonal Antibodies

APVO436 for Myelodysplastic Syndrome

Phase 1

Waitlist Available

Research Sponsored by Aptevo Research and Development LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new drug, APVO436, to see if it is safe and effective in treating patients with AML or MDS. The primary objective of the Phase 1 part of the study is to determine the recommended dose of APVO436 administered intravenously to patients with AML or MDS. The primary objective of the Phase 1b part of the study is to evaluate the clinical activity of APVO436 in patients with AML or MDS.

Eligible Conditions

Myelodysplastic Syndrome
Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 - Dose Escalation: Maximum Tolerated Dose

Part 2 - Dose Expansion: Safety

Secondary outcome measures

Part 1 - Dose Escalation: Area under the concentration-time curve (AUC)

Part 1 - Dose Escalation: Changes in T-cell populations to measure pharmacodynamics of APVO436

Part 1 - Dose Escalation: Changes in peripheral blasts to measure pharmacodynamics of APVO436

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: PART 2 Dose expansion - 5 cohortsExperimental Treatment1 Intervention

90 patients, 18/cohort in 5 dose expansion cohorts, will receive the recommended dose of APVO436 determined from Part 1

Group II: PART 1 Dose Escalation - 10 dose cohortsExperimental Treatment1 Intervention

CD123 and CD3 epsilon bispecific antibody

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Aptevo Research and Development LLCLead Sponsor

Scott C Stromatt, MDStudy DirectorAptevo Therapeutics

1 Previous Clinical Trials

35 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts underway for this experiment?

"Per clinicaltrials.gov, this ongoing medical experiment was first advertised on December 13th 2018 and was recently updated February 8th 2022. The trial remains in search of participants who meet the criteria outlined therein."

Answered by AI

What are the intended outcomes that this research seeks to achieve?

"The primary assessment of this medical trial, observed over the first month of treatment, is to measure APVO436's Maximum Tolerated Dose. Secondary outcomes include monitoring for adverse reactions according to CTCAE v5.0 standards, calculating blood concentrations with AUCs and determining efficacy based on MRD status after HSCT post protocol therapy."

Answered by AI

Are there any reported adverse outcomes associated with administering APVO436?

"APVO436 has only been tested on a limited number of clinical participants, so it was rated 1 out of 3 for safety. The paucity of data detracts from our understanding the efficacy and security associated with this drug."

Answered by AI

How many distinct sites are conducting this experiment?

"There are 9 medical sites that have enlisted for this trial, including the Sylvester Comprehensive Cancer Center/UMHC in Miami, Greenville Health System's Institute for Translational Oncology Research, and The University of Kansas Clinical Research Centre. Additionally, 6 other locations offer participation opportunities as well."

Answered by AI

How extensive is the participant pool of this clinical trial?

"This clinical trial needs 136 patients that meet the outline criteria to be conducted. The sponsor, Aptevo Research and Development LLC, is running it from a variety of sites: Sylvester Comprehensive Cancer Center/UMHC in Miami, Florida and Greenville Health System's Institute for Translational Oncology Research situated in South carolina."

Answered by AI

Recent research and studies

CancersJournal

A Clinical Phase 1B Study of the Cd3xcd123 Bispecific Antibody APVO436 in Patients with Relapsed/refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Uckun, Fatih M., Tara L. Lin, Alice S. Mims, Prapti Patel, Cynthia Lee, Anoush Shahidzadeh, Paul J. Shami, Elizabeth Cull, Christopher R. Cogle, and Justin Watts. 2021. “A Clinical Phase 1B Study of the Cd3xcd123 Bispecific Antibody APVO436 in Patients with Relapsed/refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome”. Cancers. MDPI AG. doi:10.3390/cancers13164113.

CancersJournal

Risk, Characteristics and Biomarkers of Cytokine Release Syndrome in Patients with Relapsed/refractory AML or MDS Treated with Cd3xcd123 Bispecific Antibody APVO436

Uckun, Fatih M., Justin Watts, Alice S. Mims, Prapti Patel, Eunice Wang, Paul J. Shami, Elizabeth Cull, Cynthia Lee, Christopher R. Cogle, and Tara L. Lin. 2021. “Risk, Characteristics and Biomarkers of Cytokine Release Syndrome in Patients with Relapsed/refractory AML or MDS Treated with Cd3xcd123 Bispecific Antibody APVO436”. Cancers. MDPI AG. doi:10.3390/cancers13215287.

clinicaltrials.govStudy

Study of APVO436 in Patients With AML or MDS

2018. "Study of APVO436 in Patients With AML or MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03647800.