A Study of AMG 820 in Subjects With Advanced Solid Tumors

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444404
• Other study ID #: 20060347
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2008
• Est. completion date: February 6, 2014

Study information

• Verified date: January 2023
• Source: AmMax Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 6, 2014
• Est. primary completion date: February 6, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Malignancy
• Advanced Solid Tumors
• Cancer
• Neoplasms
• Oncology
• Oncology Patients
• Tumors

Intervention

Drug:
• AMG 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.

Locations

Country	Name	City	State
United States	Research Site	Greenville	South Carolina
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AmMax Bio, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 8, 24 hours post-dose		3 years
Primary	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
Primary	Change in tumor associated macrophages (TAMS) as assessed by tumor biopsy at 9 weeks.		3 years

External Links

•   AmgenTrials clinical trials website