Study of AMV564 in Subjects With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AMV564
|
Biological: AMV564
AMV564 will be administered daily
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- Maximum observed drug concentration (Cmax) 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
- 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
- Area under the concentration-time curve (AUC) of AMV564 [Through study completion, an average of 19 months]
Measured by plasma concentration
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA | Los Angeles | California | United States | 90095 |
| 2 | Advent Health | Orlando | Florida | United States | 32803 |
| 3 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
| 4 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 5 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 6 | The Christ Hospital | Cincinnati | Ohio | United States | 45255 |
| 7 | The Ohio State University | Columbus | Ohio | United States | 43202 |
| 8 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 9 | NEXT Oncology | San Antonio | Texas | United States | 78229 |
| 10 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 11 | Peninsula Cancer Institute | Newport News | Virginia | United States | 23601 |
Sponsors and Collaborators
- Amphivena Therapeutics, Inc.
Investigators
- Study Director: Patrick Chun, MD, Amphivena Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AMV564-301