Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AmMax Bio, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
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
