Study of AMV564 in Subjects With Advanced Solid Tumors

NCT04128423 | Unknown Phase 1 FDA Drug

• 1 other identifier: AMV564-301
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 11

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.

Conditions

Locally Advanced or Metastatic Solid Tumors

Keywords

immunotherapy; anti-CD33; T-cell engager

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Maximum observed drug concentration (Cmax) of AMV564

  Through study completion, an average of 19 months

• Concentration at steady state (Css) of AMV564

  Through study completion, an average of 19 months

• Time of the maximum drug concentration (Tmax) of AMV564

  Through study completion, an average of 19 months

• Apparent terminal half-life (t½) of AMV564

  Through study completion, an average of 19 months

• Area under the concentration-time curve (AUC) of AMV564

  Through study completion, an average of 19 months

Study Arms (1)

AMV564

EXPERIMENTAL

Biological: AMV564

Interventions

AMV564 BIOLOGICAL

AMV564 will be administered daily

AMV564

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amphivena Therapeutics, Inc.: lead

Study Sites (11)

UCLA

Los Angeles, California, 90095, United States

Location

Advent Health

Orlando, Florida, 32803, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45255, United States

Location

The Ohio State University

Columbus, Ohio, 43202, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

Study Officials

• Patrick Chun, MD

  Amphivena Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 16, 2019
• Study Start: October 9, 2019
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)