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A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT03516591
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Amphivena Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome (MDS) Drug: AMV564 14-Day CIV Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation (3+3 design)
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).
Drug: AMV564 14-Day CIV
A 14-Day Continuous Intravenous Infusion regimen

Experimental: Dose Expansion
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.
Drug: AMV564 14-Day CIV
A 14-Day Continuous Intravenous Infusion regimen




Primary Outcome Measures :
  1. 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 ]
    Dose limiting toxicity to be measured by AEs and SAEs by dose level

  2. Overall Response Rate (Dose Expansion) [ Time Frame: 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. ]
    Overall response rate (ORR), defined as the proportion of patients who achieve a CR, marrow CR or PR by IWG criteria. Point estimates for ORR, along with the approximate lower 1-sided 90% confidence intervals, will be calculated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516591


Contacts
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Contact: Clinical Operations 1-833-AMPHITX (267-4489) clinical@amphivena.com

Locations
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United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Baishakhi (Ruma) Barva       bbarva@coh.org   
Principal Investigator: Samer Khaled, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: William Cisneros Prada       William.CisnerosPrada@moffitt.org   
Principal Investigator: David Sallman, MD         
United States, Missouri
Washington University, Siteman Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Megan Haney       haneym@wustl.edu   
Principal Investigator: Meagan Jacoby, MD         
United States, Ohio
Ohio State University Comprehensive Cancer Center Not yet recruiting
Columbus, Ohio, United States, 42310
Contact: Meixiao Long, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Meghan Meyer, RN, BSN, OCN, BMTCN    713-792-5615    MAMeyer@mdanderson.org   
Principal Investigator: Guillermo Garcia-Manero, MD         
Sponsors and Collaborators
Amphivena Therapeutics, Inc.
Investigators
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Study Director: Eric Feldman, MD Amphivena Therapeutics, Inc.

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Responsible Party: Amphivena Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03516591     History of Changes
Other Study ID Numbers: AMV564-201
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms