Study of AMV564 in Subjects With Advanced Solid Tumors
- Conditions
- Locally Advanced or Metastatic Solid Tumors
- Interventions
- Biological: AMV564
- Registration Number
- NCT04128423
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 65
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMV564 AMV564 -
- Primary Outcome Measures
Name Time Method Maximum tolerated dose of AMV564 in subjects with advanced solid tumors During Dose Escalation, an average of 6 months As determined based on the occurrence of dose-limiting toxicity
Incidence of Treatment-Related Adverse Events Through study completion, an average of 19 months As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs
Preliminary evaluation of AMV564 efficacy in subjects enrolled in the expansion phase During Dose Expansion, an average of 1 year As measured by the objective response rate (ORR)
- Secondary Outcome Measures
Name Time Method Maximum observed drug concentration (Cmax) of AMV564 Through study completion, an average of 19 months Measured by plasma concentration
Time of the maximum drug concentration (Tmax) of AMV564 Through study completion, an average of 19 months Measured by plasma concentration
Apparent terminal half-life (t½) of AMV564 Through study completion, an average of 19 months Measured by plasma concentration
Concentration at steady state (Css) of AMV564 Through study completion, an average of 19 months Measured by plasma concentration
Area under the concentration-time curve (AUC) of AMV564 Through study completion, an average of 19 months Measured by plasma concentration
Trial Locations
- Locations (11)
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Peninsula Cancer Institute
🇺🇸Newport News, Virginia, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Advent Health
🇺🇸Orlando, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States
UCLA
🇺🇸Los Angeles, California, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States