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NCT02437916 Clinical Trial

Safety Study of AMG 228 to Treat Solid Tumors

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02437916
Other study ID # 20140131
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date April 21, 2015
Est. completion date December 12, 2016

Study information
Verified date November 2022
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date December 12, 2016
Est. primary completion date December 12, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AMG 228
AMG 228 will be administered intravenously

Locations
Country Name City State
Australia Research Site Parkville Victoria
Belgium Research Site Leuven
France Research Site Villejuif
Germany Research Site Heidelberg
United States Research Site La Jolla California
United States Research Site New Haven Connecticut
United States Research Site New York New York

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany, 

References & Publications (1)

Tran B, Carvajal RD, Marabelle A, Patel SP, LoRusso PM, Rasmussen E, Juan G, Upreti VV, Beers C, Ngarmchamnanrith G, Schöffski 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Subject incidence of dose limiting toxicities (DLT) 9 months
Primary Subject incidence of treatment-emergent adverse events 9 months
Primary Subject incidence of treatment-related adverse events 9 months
Primary Subject incidence of clinically significant changes in vital signs and physical assessments 9 months
Primary Subject incidence of clinically significant changes in ECGs 9 months
Primary Subject incidence of clinically significant changes in clinical laboratory tests 9 months
Primary AMG 228 maximum observed concentration (Cmax) 9 months
Primary AMG 228 minimum observed concentration (Cmin) 9 months
Primary AMG 228 area under the concentration-time curve (AUC) 9 months
Primary AMG 228 half-life (t1/2) 9 months
Secondary Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 9 months
Secondary Incidence of anti-AMG 228 antibody formation 9 months
Secondary Activation status and changes in numbers of T regulator cells (Treg) 9 months
Secondary Subject objective response per immune-related Response Criteria (irRC) 9 months
Secondary Activation status of cytotoxic T lymphocytes (CTL) 9 months
Secondary Changes in numbers of cytotoxic T lymphocytes (CTL) 9 months
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