Description:
An open label, Phase 1, study of AMV564 as monotherapy to assess the safety and efficacy in patients with Myelodysplastic Syndromes
An open label, Phase 1, study of AMV564 as monotherapy to assess the safety and efficacy in patients with Myelodysplastic Syndromes
Active, not recruiting
Phase 1
Drug | Synonyms | Arms |
---|---|---|
AMV564 14-Day CIV | Dose Escalation (3+3 design) |
A dose-escalation with expansion study of AMV564 (T cell engager) as monotherapy in patients with intermediate-2 or high-risk Myelodysplastic Syndromes
Name | Type | Description | Interventions |
---|---|---|---|
Dose Escalation (3+3 design) | Experimental | A 3 + 3 design, with dose-escalation of AMV564, up to a Maximum Tolerated Dose (MTD) level. AMV564 will be tested as a 14-Day CIV regimen (14-Day Continuous Intravenous Infusion Regimen). |
|
Dose Expansion | Experimental | Following determination of the MTD of AMV564, the study will expand at the MTD or a dose level lower than the MTD to obtain initial estimates of response rates and additional information on safety. |
|
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).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Dose limiting toxicity (Dose Escalation) |
Time Frame: | 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 |
Safety Issue: | |
Description: | Dose limiting toxicity to be measured by AEs and SAEs by dose level |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Amphivena Therapeutics, Inc. |
May 22, 2020