Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
65 participants
INTERVENTIONAL
2019-10-09
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AMV564
AMV564
AMV564 will be administered daily
Interventions
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AMV564
AMV564 will be administered daily
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Amphivena Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick Chun, MD
Role: STUDY_DIRECTOR
Amphivena Therapeutics
Locations
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UCLA
Los Angeles, California, United States
Advent Health
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Duke University Medical Center
Durham, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Countries
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Other Identifiers
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AMV564-301
Identifier Type: -
Identifier Source: org_study_id