A Study of AMG 820 in Subjects With Advanced Solid Tumors

AmMax Bio

Status and phase: Completed; Phase 1

Conditions: Tumors; Oncology; Advanced Malignancy; Advanced Solid Tumors; Cancer; Oncology Patients

Treatments: Drug: AMG 820

Study type: Interventional

Funder types: Industry

Identifiers

NCT01444404

20060347

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Dose Expansion

Experimental group

Description:

The 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.

Treatment:

Drug: AMG 820

Dose Escalation

Experimental group

Description:

The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 820.

Treatment:

Drug: AMG 820