Study of AMV564 in Subjects With Advanced Solid Tumors

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Locally Advanced or Metastatic Solid Tumors
• Intervention / Treatment: Biological: AMV564

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: Interventional
• Enrollment (Anticipated): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
  • Florida
    • Orlando, Florida, United States, 32803
      • Advent Health
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45255
      • The Christ Hospital
    • Columbus, Ohio, United States, 43202
      • The Ohio State University
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • NEXT Oncology
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Newport News, Virginia, United States, 23601
      • Peninsula Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AMV564	Biological: AMV564; AMV564 will be administered daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Related Adverse Events	As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs	Through study completion, an average of 19 months
Maximum tolerated dose of AMV564 in subjects with advanced solid tumors	As determined based on the occurrence of dose-limiting toxicity	During Dose Escalation, an average of 6 months
Preliminary evaluation of AMV564 efficacy in subjects enrolled in the expansion phase	As measured by the objective response rate (ORR)	During Dose Expansion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 9, 2019
• Primary Completion (ANTICIPATED): December 15, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (ACTUAL): October 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: immunotherapy; anti-CD33; T-cell engager
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: AMV564-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No