Clinical Trials /

Study of AMV564 in Subjects With Advanced Solid Tumors

NCT04128423

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of AMV564 in Subjects With Advanced Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: AMV564-301
  • NCT ID: NCT04128423

Conditions

  • Locally Advanced or Metastatic Solid Tumors

Interventions

DrugSynonymsArms
AMV564AMV564

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
AMV564Experimental
  • AMV564

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Treatment-Related Adverse Events
Time Frame:Through study completion, an average of 19 months
Safety Issue:
Description:As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs

Secondary Outcome Measures

Measure:Maximum observed drug concentration (Cmax) of AMV564
Time Frame:Through study completion, an average of 19 months
Safety Issue:
Description:Measured by plasma concentration
Measure:Concentration at steady state (Css) of AMV564
Time Frame:Through study completion, an average of 19 months
Safety Issue:
Description:Measured by plasma concentration
Measure:Time of the maximum drug concentration (Tmax) of AMV564
Time Frame:Through study completion, an average of 19 months
Safety Issue:
Description:Measured by plasma concentration
Measure:Apparent terminal half-life (t½) of AMV564
Time Frame:Through study completion, an average of 19 months
Safety Issue:
Description:Measured by plasma concentration
Measure:Area under the concentration-time curve (AUC) of AMV564
Time Frame:Through study completion, an average of 19 months
Safety Issue:
Description:Measured by plasma concentration

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Amphivena Therapeutics, Inc.

Trial Keywords

  • immunotherapy
  • anti-CD33
  • T-cell engager

Last Updated

December 3, 2019