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

Sponsor
Amphivena Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03516591
Collaborator
(none)
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Study Details

Study Description

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
  • 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

Study Design

Study Type:
Interventional
Actual Enrollment :
14 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 :
Jun 22, 2018
Actual Primary Completion Date :
Jul 31, 2020
Actual Study Completion Date :
Jul 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Dose limiting toxicity (Dose Escalation) [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) [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.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 City of Hope Comprehensive Cancer Center Duarte California United States 91010
2 Moffitt Cancer Center Tampa Florida United States 33612
3 Washington University, Siteman Cancer Center Saint Louis Missouri United States 63110
4 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 42310
5 MD Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • Amphivena Therapeutics, Inc.

Investigators

  • Study Director: Patrick Chun, MD, Amphivena Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amphivena Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03516591
Other Study ID Numbers:
  • AMV564-201
First Posted:
May 4, 2018
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021