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.
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 13 Secondary · Reporting Duration: 2 years
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
PART 1 Dose Escalation - 10 dose cohorts
1 of 2
PART 2 Dose expansion - 5 cohorts
1 of 2
Experimental Treatment
136 Total Participants · 2 Treatment Groups
Primary Treatment: APVO436 · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- 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.
- Uckun FM, Watts J, Mims AS, Patel P, Wang E, Shami PJ, Cull E, Lee C, Cogle CR, Lin TL. Risk, Characteristics and Biomarkers of Cytokine Release Syndrome in Patients with Relapsed/Refractory AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436. Cancers. 2021; 13(21):5287. https://doi.org/10.3390/cancers13215287
- 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.
- Uckun FM, Watts J, Mims AS, Patel P, Wang E, Shami PJ, Cull E, Lee C, Cogle CR, Lin TL. Risk, Characteristics and Biomarkers of Cytokine Release Syndrome in Patients with Relapsed/Refractory AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436. Cancers (Basel). 2021 Oct 21;13(21):5287. doi: 10.3390/cancers13215287.
- Uckun FM, Lin TL, Mims AS, Patel P, Lee C, Shahidzadeh A, Shami PJ, Cull E, Cogle CR, Watts J. A Clinical Phase 1B Study of the CD3xCD123 Bispecific Antibody APVO436 in Patients with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. Cancers (Basel). 2021 Aug 15;13(16):4113. doi: 10.3390/cancers13164113.
- 2018. "Study of APVO436 in Patients With AML or MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03647800.
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor