Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT04128423
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Amphivena Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 10, 2019
First Posted Date  ICMJE October 16, 2019
Last Update Posted Date May 14, 2021
Actual Study Start Date  ICMJE October 9, 2019
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
  • 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
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
  • Maximum observed drug concentration (Cmax) of AMV564 [ Time Frame: Through study completion, an average of 19 months ]
    Measured by plasma concentration
  • Concentration at steady state (Css) of AMV564 [ Time Frame: Through study completion, an average of 19 months ]
    Measured by plasma concentration
  • Time of the maximum drug concentration (Tmax) of AMV564 [ Time Frame: Through study completion, an average of 19 months ]
    Measured by plasma concentration
  • Apparent terminal half-life (t½) of AMV564 [ Time Frame: Through study completion, an average of 19 months ]
    Measured by plasma concentration
  • Area under the concentration-time curve (AUC) of AMV564 [ Time Frame: Through study completion, an average of 19 months ]
    Measured by plasma concentration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of AMV564 in Subjects With Advanced Solid Tumors
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced or Metastatic Solid Tumors
Intervention  ICMJE Biological: AMV564
AMV564 will be administered daily
Study Arms  ICMJE Experimental: AMV564
Intervention: Biological: AMV564
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2019)
116
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2019)
92
Estimated Study Completion Date  ICMJE September 15, 2022
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amphivena Therapeutics 1-833-AMPHITX (267-4489) clinical@amphivena.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04128423
Other Study ID Numbers  ICMJE AMV564-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amphivena Therapeutics, Inc.
Study Sponsor  ICMJE Amphivena Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Patrick Chun, MD Amphivena Therapeutics
PRS Account Amphivena Therapeutics, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP