A Study of AMG 820 in Subjects With Advanced Solid Tumors
A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics of AMG 820 in Adult Subjects With Advanced Solid Tumors
1 other identifier
interventional
25
1 country
3
Brief Summary
First in human, open-label, sequential dose escalation and expansion study of AMG 820 in subjects with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2008
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2008
CompletedFirst Submitted
Initial submission to the registry
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2014
CompletedJanuary 19, 2023
January 1, 2023
5.9 years
September 1, 2011
January 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 8, 24 hours post-dose
3 years
Dose of AMG 820 where clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled is greater than 33%.
3 years
Change in tumor associated macrophages (TAMS) as assessed by tumor biopsy at 9 weeks.
3 years
Study Arms (2)
Dose Expansion
EXPERIMENTALThe dose expansion will consist of up to 20 subjects and the dose level of AMG 820 will be dependent upon emerging safety and PK data from the dose escalation part of the study.
Dose Escalation
EXPERIMENTALThe dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 820.
Interventions
AMG 820 is a fully human IgG2 c-fms antagonistic antibody and will be given every two weeks until progression or unacceptable toxicity develops.
Eligibility Criteria
You may qualify if:
- Men or women ≥ 18 years old
- Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor
- Measurable disease per RECIST 1.1 guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Part 2 - Dose Expansion only: Subjects must have tumor tissue that is accessible for core needle biopsy by using minimally invasive procedures and must consent to undergo biopsies of the tumor
- Able to fast 4 to 6 hours for FDG-PET/CT scan, except subjects with prostate or bladder cancers
- Competent to sign and date an Institutional Review Board approved informed consent form
- Adequate hematologic, renal and hepatic function as determined by laboratory blood and urine tests
You may not qualify if:
- Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and an additional 4 months after receiving the last dose of study drug.
- Women who are lactating/breastfeeding or planning to become pregnant during the duration of the study
- Primary central nervous system (CNS) tumors or CNS metastases
- History of presence of hematological malignancies
- History of arterial or venous thrombosis within 6 months of study enrollment
- History of bleeding diathesis
- Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension
- Hypertension not adequately controlled with medication (diastolic \> 90mmHG; systolic \> 140 mmHG)
- Left ventricular ejection fraction (LVEF) ≤ 50%
- Active infection requiring (IV) antibiotics within 2 weeks of study enrollment
- Known positive test for human immunodeficiency virus (HIV)
- Known chronic hepatitis B or hepatitis C infection
- Positive test for hepatitis B surface antigen or hepatitis C antibody
- Known history of tuberculosis (TB), exposure to active TB-infected individuals, or positive TB skin test (tuberculin or purified protein derivative (PPD) test) upon study entry (subjects previously vaccinated for TB are not excluded unless there is evidence of active TB)
- Anti-tumor therapy within 4 weeks of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AmMax Bio, Inc.lead
Study Sites (3)
Research Site
Philadelphia, Pennsylvania, 19111, United States
Research Site
Greenville, South Carolina, 29605, United States
Research Site
San Antonio, Texas, 78229, United States
Related Publications (1)
Papadopoulos KP, Gluck L, Martin LP, Olszanski AJ, Tolcher AW, Ngarmchamnanrith G, Rasmussen E, Amore BM, Nagorsen D, Hill JS, Stephenson J Jr. First-in-Human Study of AMG 820, a Monoclonal Anti-Colony-Stimulating Factor 1 Receptor Antibody, in Patients with Advanced Solid Tumors. Clin Cancer Res. 2017 Oct 1;23(19):5703-5710. doi: 10.1158/1078-0432.CCR-16-3261. Epub 2017 Jun 27.
PMID: 28655795BACKGROUND
Related Links
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2011
First Posted
September 30, 2011
Study Start
March 31, 2008
Primary Completion
February 6, 2014
Study Completion
February 6, 2014
Last Updated
January 19, 2023
Record last verified: 2023-01