Advanced Malignancy, Advanced Solid Tumors, Cancer, Oncology, Oncology Patients, Tumors
Conditions
Keywords
Solid Tumors, Phase 1, Clinical Trial
Brief summary
First in human, open-label, sequential dose escalation and expansion study of AMG 820 in subjects with advanced solid tumors.
Interventions
DRUGAMG 820
AMG 820 is a fully human IgG2 c-fms antagonistic antibody and will be given every two weeks until progression or unacceptable toxicity develops.
Sponsors
AmMax Bio, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed