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Study of AMV564 in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04128423
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : May 14, 2021
Information provided by (Responsible Party):
Amphivena Therapeutics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Solid Tumors Biological: AMV564 Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation With Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMV564 Alone and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : September 15, 2022

Arm Intervention/treatment
Experimental: AMV564 Biological: AMV564
AMV564 will be administered daily

Primary Outcome Measures :
  1. Incidence of Treatment-Related Adverse Events [ Time Frame: Through study completion, an average of 19 months ]
    As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs

  2. Maximum tolerated dose of AMV564 in subjects with advanced solid tumors [ Time Frame: During Dose Escalation, an average of 6 months ]
    As determined based on the occurrence of dose-limiting toxicity

  3. Preliminary evaluation of AMV564 efficacy in subjects enrolled in the expansion phase [ Time Frame: During Dose Expansion, an average of 1 year ]
    As measured by the objective response rate (ORR)

Secondary Outcome Measures :
  1. Maximum observed drug concentration (Cmax) of AMV564 [ Time Frame: Through study completion, an average of 19 months ]
    Measured by plasma concentration

  2. Concentration at steady state (Css) of AMV564 [ Time Frame: Through study completion, an average of 19 months ]
    Measured by plasma concentration

  3. Time of the maximum drug concentration (Tmax) of AMV564 [ Time Frame: Through study completion, an average of 19 months ]
    Measured by plasma concentration

  4. Apparent terminal half-life (t½) of AMV564 [ Time Frame: Through study completion, an average of 19 months ]
    Measured by plasma concentration

  5. Area under the concentration-time curve (AUC) of AMV564 [ Time Frame: Through study completion, an average of 19 months ]
    Measured by plasma concentration

Information from the National Library of Medicine

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

Key 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

Key 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

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 identifier (NCT number): NCT04128423

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Contact: Amphivena Therapeutics 1-833-AMPHITX (267-4489)

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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Zev Wainberg, MD         
United States, Florida
Advent Health Recruiting
Orlando, Florida, United States, 32803
Principal Investigator: George Simon, MD         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Michael Shafique, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Jeffrey Sosman, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Niharika Mettu, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45255
Principal Investigator: Alexander Starodub, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43202
Principal Investigator: Gabriel Tinoco, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Sarina Piha-Paul, MD         
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: David Sommerhalder, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: Robert Dreicer, MD         
Peninsula Cancer Institute Completed
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
Amphivena Therapeutics, Inc.
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Study Director: Patrick Chun, MD Amphivena Therapeutics
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Responsible Party: Amphivena Therapeutics, Inc. Identifier: NCT04128423    
Other Study ID Numbers: AMV564-301
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amphivena Therapeutics, Inc.:
T-cell engager
Additional relevant MeSH terms:
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