Clinical trial NCT03516591: A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes
Official title: A Phase 1, Multicenter, Open Label Study of AMV564, a Bispecific CD33/CD3 T-cell Engager, in Patients With Intermediate or High-Risk Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myelodysplastic Syndrome (MDS)
Lead sponsor: Amphivena Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: An open label, Phase 1, study of AMV564 as monotherapy to assess the safety and efficacy in patients with Myelodysplastic Syndromes

Detailed description: A dose-escalation with expansion study of AMV564 (T cell engager) as monotherapy in patients with intermediate-2 or high-risk Myelodysplastic Syndromes

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Diagnosis of MDS according to WHO 2016 criteria
* ECOG performance status of 0 or 1
* Intermediate-2 or high-risk disease per IPSS
* Fewer than 20% blasts in the bone marrow or peripheral blood
* Disease that is refractory to or relapsed from either a hypomethylating agent (e.g. decitabine or azacitidine) or a standard AML-type intensive regimen
* Adequate organ function
* Prior allogeneic transplant performed ≥ 3 months prior to first dose of AMV564 is allowed provided there is no evidence of active graft-versus-host disease (GVHD) and the patient has been off immunosuppressive therapy for ≥ 4 weeks.

Exclusion Criteria:

* History of, or known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ≥ 3 drug-related CNS toxicity
* Prior allogeneic transplant if performed \< 3 months prior to first dose of AMV564, if patient has active GVHD, or if patient has not been off immunosuppressive
* Prior treatment with a therapeutic agent targeting CD33 (e.g. gemtuzumab ozogamicin, SGN-CD33A or AMG 330).

Primary outcomes:
measure: Dose limiting toxicity (Dose Escalation)
timeFrame: DLTs will be evaluated through 28 days for the 14-Day Continuous Intravenous Infusion Infusion regimen, and 35 days for the Intermittent Intravenous Dosing regimen
measure: Overall Response Rate (Dose Expansion)
timeFrame: The treatment period will extend from initiation of AMV564 treatment until the Safety Follow Up visit (30 days after the end of infusion), or response assessment of the last induction cycle, whichever occurs later.
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Saint Louis
country: United States
facility: Washington University, Siteman Cancer Center
state: Missouri
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Amphivena Therapeutics, Inc.
name: Patrick Chun, MD
role: STUDY_DIRECTOR
References: