A Study of AMG 820 in Subjects With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumors; Cancer; Oncology; Tumors; Advanced Malignancy; Oncology Patients
• Interventions: Drug: AMG 820

• Registration Number: NCT01444404
• Lead Sponsor: AmMax Bio, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-31
• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Primary Completion: 2014-02-06
• Study Completion: 2014-02-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Expansion	AMG 820	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.
Dose Escalation	AMG 820	The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 820.

Primary Outcome Measures

Name	Time	Method
Change in tumor associated macrophages (TAMS) as assessed by tumor biopsy at 9 weeks.	3 years
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States