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Study of AMV564 in Subjects With Advanced Solid Tumors

Trial Status: Active

This Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMV564 alone and in combination with Pembrolizumab in patients with advanced solid tumors.

Inclusion Criteria

  • 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard therapy exists
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or per other criteria best suited for the specific tumor type being evaluated
  • Willing to complete all scheduled visits and assessments at the institution administering therapy

Exclusion Criteria

  • Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of AMV564
  • Major trauma or major surgery within 4 weeks prior to first dose of AMV564
  • Prior treatment with chimeric antigen receptor (CAR) T-cell therapy or T-cell engager therapy
  • Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of AMV564
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia
  • Known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≥ 3 drug-related CNS toxicity

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Lisa Yonemoto
Phone: 310-825-4477

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: IN_REVIEW

AMV564-301 is a Phase 1, open-label, multicenter dose-escalation with expansion trial in

patients with locally advanced or metastatic solid tumors. In the dose-escalation portion of

the study, cohorts of patients will receive AMV564 alone or in combination with Pembrolizumab

at increasing dose levels to determine the maximum tolerated dose (MTD) and/or the

recommended dose for expansion. In the expansion portion of the study, one or more cohorts of

patients will receive AMV564 at the MTD or recommended dose to further evaluate safety,

tolerability, and clinical activity.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Amphivena Therapeutics, Inc.

  • Primary ID AMV564-301
  • Secondary IDs NCI-2019-07728
  • Clinicaltrials.gov ID NCT04128423