Clinical trial NCT01444404: A Study of AMG 820 in Subjects With Advanced Solid Tumors
Official title: A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics of AMG 820 in Adult Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancy
Advanced Solid Tumors
Cancer
Oncology
Oncology Patients
Tumors
Keywords: Solid Tumors
Phase 1
Clinical Trial
Lead sponsor: AmMax Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: First in human, open-label, sequential dose escalation and expansion study of AMG 820 in subjects with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Concurrent or prior anticoagulation therapy within 28 days of study day 1
* Major surgery within 28 days of study day 1
* Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor

Primary outcomes:
measure: Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 8, 24 hours post-dose
timeFrame: 3 years
measure: 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%.
timeFrame: 3 years
measure: Change in tumor associated macrophages (TAMS) as assessed by tumor biopsy at 9 weeks.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.