Advanced MalignancyPhase 1NCT01444404
A Study of AMG 820 in Subjects With Advanced Solid Tumors
A Phase 1 study testing AMG 820 in people with Advanced Malignancy and Advanced Solid Tumors, run by AmMax Bio, Inc. at 3 sites in United States.
Trial summary
First in human, open-label, sequential dose escalation and expansion study of AMG 820 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancy, Advanced Solid Tumors, Cancer
- What is being tested?
- AMG 820
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Mar 2008to 6 Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Greenville, South Carolina, 29605
Research Site
Philadelphia, Pennsylvania, 19111
Research Site
San Antonio, Texas, 78229
About this study
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
First in human, open-label, sequential dose escalation and expansion study of AMG 820 in subjects with advanced solid tumors.
- Conditions
- Advanced Malignancy, Advanced Solid Tumors, Cancer, Oncology, Oncology Patients, Tumors
- Being tested
- AMG 820
- Keywords
- Solid Tumors, Phase 1, Clinical Trial
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 820Drug
AMG 820 is a fully human IgG2 c-fms antagonistic antibody and will be given every two weeks until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| Dose Expansion | Experimental | 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. Receives: Drug: AMG 820 |
| Dose Escalation | Experimental | The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 820. Receives: Drug: AMG 820 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 8, 24 hours post-dose
Measured: 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%.
Measured: 3 years
Change in tumor associated macrophages (TAMS) as assessed by tumor biopsy at 9 weeks.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study start31 Mar 2008
- Primary completion6 Feb 2014
- Study completion6 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AmMax Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444404
- Sponsor's protocol ID
- 20060347
- Status last verified
- Jan 2023
- First submitted
- 1 Sep 2011
- Last updated
- 19 Jan 2023
- Results posted
- No
Publications
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.
PubMed 28655795
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01444404
- Acronym / sponsor ID
- 20060347
- Conditions
- Advanced Malignancy, Advanced Solid Tumors, Cancer, Oncology, Oncology Patients, Tumors
- Keywords
- Solid Tumors, Phase 1, Clinical Trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AmMax Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2008 (actual)
- Primary completion
- 6 Feb 2014 (actual)
- Study completion
- 6 Feb 2014 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First in human, open-label, sequential dose escalation and expansion study of AMG 820 in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Expansion | Experimental | Drug: AMG 820The 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 | Experimental | Drug: AMG 820The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 820. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 820AMG 820 is a fully human IgG2 c-fms antagonistic antibody and will be given every two weeks until progression or unacceptable toxicity develops. | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 8, 24 hours post-dose
Time frame: 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%.
Time frame: 3 years
Change in tumor associated macrophages (TAMS) as assessed by tumor biopsy at 9 weeks.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 28655795Papadopoulos 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 820 in people with Advanced Malignancy and Advanced Solid Tumors, run by AmMax Bio, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 8, 24 hours post-dose (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01444404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.