Safety Study of AMG 228 to Treat Solid Tumors

NCT02437916 | Terminated Phase 1

• 1 other identifier: 20140131
• Study Type: interventional
• Target: 30
• Locations: 5 countries
• Sites: 7

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.

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)

Outcome Measures

Primary Outcomes (10)

• Subject incidence of dose limiting toxicities (DLT)

  9 months

• Subject incidence of treatment-emergent adverse events

  9 months

• Subject incidence of treatment-related adverse events

  9 months

• Subject incidence of clinically significant changes in vital signs and physical assessments

  9 months

• Subject incidence of clinically significant changes in ECGs

  9 months

• Subject incidence of clinically significant changes in clinical laboratory tests

  9 months

• AMG 228 maximum observed concentration (Cmax)

  9 months

• AMG 228 minimum observed concentration (Cmin)

  9 months

• AMG 228 area under the concentration-time curve (AUC)

  9 months

• AMG 228 half-life (t1/2)

  9 months

Secondary Outcomes (6)

• Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  9 months

• Incidence of anti-AMG 228 antibody formation

  9 months

• Activation status and changes in numbers of T regulator cells (Treg)

  9 months

• Subject objective response per immune-related Response Criteria (irRC)

  9 months

• Activation status of cytotoxic T lymphocytes (CTL)

  9 months

Study Arms (1)

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.

Drug: AMG 228

Interventions

AMG 228 DRUG

AMG 228 will be administered intravenously

AMG 228 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (7)

Research Site

La Jolla, California, 92093, United States

Location

Research Site

New Haven, Connecticut, 06520, United States

Location

Research Site

New York, New York, 10032, United States

Location

Research Site

Parkville, Victoria, 3050, Australia

Location

Research Site

Leuven, 3000, Belgium

Location

Research Site

Villejuif, 94805, France

Location

Research Site

Heidelberg, 69120, Germany

Location

Related Publications (1)

• 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.

  PMID: 30253804 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neoplasms; Melanoma; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Colorectal Neoplasms; Carcinoma, Squamous Cell; Carcinoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Squamous Cell

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: May 8, 2015
• Study Start: April 21, 2015
• Primary Completion: December 12, 2016
• Study Completion: December 12, 2016
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

BE (1); FR (1); DE (1); US (3); AU (1)