Clinical trial NCT02437916: Safety Study of AMG 228 to Treat Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Malignancy
Advanced Solid Tumors
Cancer
Oncology
Oncology Patients
Tumors
Melanoma
Non-small Cell Lung Cancer
Squamous Cell Carcinoma of the Head and Neck
Transitional Cell Carinoma of Bladder
Colorectal Cancer
Keywords: Melanoma
Non-small Cell Lung Cancer (NSCLC)
Squamous Cell Carcinoma
Carcinoma
Head and Neck
Transitional Cell Carinoma (TCC)
Bladder
Colorectal
Colorectal Cancer (CRC)
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
* Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria:

* 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

Primary outcomes:
measure: Subject incidence of dose limiting toxicities (DLT)
timeFrame: 9 months
measure: Subject incidence of treatment-emergent adverse events
timeFrame: 9 months
measure: Subject incidence of treatment-related adverse events
timeFrame: 9 months
measure: Subject incidence of clinically significant changes in vital signs and physical assessments
timeFrame: 9 months
measure: Subject incidence of clinically significant changes in ECGs
timeFrame: 9 months
measure: Subject incidence of clinically significant changes in clinical laboratory tests
timeFrame: 9 months
measure: AMG 228 maximum observed concentration (Cmax)
timeFrame: 9 months
measure: AMG 228 minimum observed concentration (Cmin)
timeFrame: 9 months
measure: AMG 228 area under the concentration-time curve (AUC)
timeFrame: 9 months
measure: AMG 228 half-life (t1/2)
timeFrame: 9 months
Secondary outcomes:
measure: Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
timeFrame: 9 months
measure: Incidence of anti-AMG 228 antibody formation
timeFrame: 9 months
measure: Activation status and changes in numbers of T regulator cells (Treg)
timeFrame: 9 months
measure: Subject objective response per immune-related Response Criteria (irRC)
timeFrame: 9 months
measure: Activation status of cytotoxic T lymphocytes (CTL)
timeFrame: 9 months
measure: Changes in numbers of cytotoxic T lymphocytes (CTL)
timeFrame: 9 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: New York
country: United States
facility: Research Site
state: New York
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Leuven
country: Belgium
facility: Research Site
city: Villejuif
country: France
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.