Advanced MalignancyPhase 1NCT02437916
Safety Study of AMG 228 to Treat Solid Tumors
A Phase 1 study testing AMG 228 in people with Advanced Malignancy and Advanced Solid Tumors, run by Amgen at 7 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 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 228
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 21 Apr 2015to 12 Dec 2016
- 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
- Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
- Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Who cannot join
- Active autoimmune disease, history of autoimmune disease
- Treatment with immune modulators including
- Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days
- Major surgery within 28 days of study day 1
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
United States3 sites
Research Site
La Jolla, California, 92093
Research Site
New Haven, Connecticut, 06520
Research Site
New York, New York, 10032
About this study
Official title: A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors
The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.
- Conditions
- Advanced Malignancy, Advanced Solid Tumors, Cancer, Oncology, Oncology Patients, Tumors
- Being tested
- AMG 228
- Keywords
- Melanoma, Non-small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma, Carcinoma, Head and Neck, Transitional Cell Carinoma (TCC), Bladder, Colorectal, Colorectal Cancer (CRC)
- Medical subject headings
- Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms, Carcinoma, Squamous Cell, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 228Drug
AMG 228 will be administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| AMG 228 monotherapy | Experimental | Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types. Receives: Drug: AMG 228 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of dose limiting toxicities (DLT)
Measured: 9 months
Subject incidence of treatment-emergent adverse events
Measured: 9 months
Subject incidence of treatment-related adverse events
Measured: 9 months
Subject incidence of clinically significant changes in vital signs and physical assessments
Measured: 9 months
Subject incidence of clinically significant changes in ECGs
Measured: 9 months
Subject incidence of clinically significant changes in clinical laboratory tests
Measured: 9 months
AMG 228 maximum observed concentration (Cmax)
Measured: 9 months
AMG 228 minimum observed concentration (Cmin)
Measured: 9 months
AMG 228 area under the concentration-time curve (AUC)
Measured: 9 months
AMG 228 half-life (t1/2)
Measured: 9 months
Secondary outcomes (6)
Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: 9 months
Incidence of anti-AMG 228 antibody formation
Measured: 9 months
Activation status and changes in numbers of T regulator cells (Treg)
Measured: 9 months
Subject objective response per immune-related Response Criteria (irRC)
Measured: 9 months
Activation status of cytotoxic T lymphocytes (CTL)
Measured: 9 months
Changes in numbers of cytotoxic T lymphocytes (CTL)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start21 Apr 2015
- Primary completion12 Dec 2016
- Study completion12 Dec 2016
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.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437916
- Sponsor's protocol ID
- 20140131
- Status last verified
- Nov 2022
- First submitted
- 3 Apr 2015
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Tran B, Carvajal RD, Marabelle A, Patel SP, LoRusso PM, Rasmussen E, Juan G, Upreti VV, Beers C, Ngarmchamnanrith G, Schoffski P. Dose escalation results from a first-in-human, phase 1 study of glucocorticoid-induced TNF receptor-related protein agonist AMG 228 in patients with advanced solid tumors. J Immunother Cancer. 2018 Sep 25;6(1):93. doi: 10.1186/s40425-018-0407-x.
PubMed 30253804
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. 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 Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02437916
- Acronym / sponsor ID
- 20140131
- Conditions
- Advanced Malignancy, Advanced Solid Tumors, Cancer, Oncology, Oncology Patients, Tumors
- Keywords
- Melanoma, Non-small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma, Carcinoma, Head and Neck, Transitional Cell Carinoma (TCC), Bladder, Colorectal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2015 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 12 Dec 2016 (actual)
- First posted
- 8 May 2015 (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.
The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMG 228 monotherapy | Experimental | Drug: AMG 228Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
- Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Key exclusion criteria (5 listed)
- Active autoimmune disease, history of autoimmune disease
- Treatment with immune modulators including
- Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days
- Major surgery within 28 days of study day 1
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 228AMG 228 will be administered intravenously | Drug | AMG 228 monotherapy |
Primary outcome
Subject incidence of dose limiting toxicities (DLT)
Time frame: 9 months
Subject incidence of treatment-emergent adverse events
Time frame: 9 months
Subject incidence of treatment-related adverse events
Time frame: 9 months
Subject incidence of clinically significant changes in vital signs and physical assessments
Time frame: 9 months
Subject incidence of clinically significant changes in ECGs
Time frame: 9 months
Subject incidence of clinically significant changes in clinical laboratory tests
Time frame: 9 months
AMG 228 maximum observed concentration (Cmax)
Time frame: 9 months
AMG 228 minimum observed concentration (Cmin)
Time frame: 9 months
AMG 228 area under the concentration-time curve (AUC)
Time frame: 9 months
AMG 228 half-life (t1/2)
Time frame: 9 months
6 secondary outcomes
Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: 9 months
Incidence of anti-AMG 228 antibody formation
Time frame: 9 months
Activation status and changes in numbers of T regulator cells (Treg)
Time frame: 9 months
Subject objective response per immune-related Response Criteria (irRC)
Time frame: 9 months
Activation status of cytotoxic T lymphocytes (CTL)
Time frame: 9 months
Changes in numbers of cytotoxic T lymphocytes (CTL)
Time frame: 9 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 30253804Tran B, Carvajal RD, Marabelle A, Patel SP, LoRusso PM, Rasmussen E, Juan G, Upreti VV, Beers C, Ngarmchamnanrith G, Schoffski P. Dose escalation results from a first-in-human, phase 1 study of glucocorticoid-induced TNF receptor-related protein agonist AMG 228 in patients with advanced solid tumors. J Immunother Cancer. 2018 Sep 25;6(1):93. doi: 10.1186/s40425-018-0407-x.
- 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
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 228 in people with Advanced Malignancy and Advanced Solid Tumors, run by Amgen at 7 sites in 5 countries.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia, Belgium, France, Germany. 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 was stopped early. Results are not available in the source record.
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?
Subject incidence of dose limiting toxicities (DLT) (time frame: 9 months). The study lists 10 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 NCT02437916, 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 8 Nov 2022.