Clinical trial · Interventional
Safety Study of AMG 228 to Treat Solid Tumors
A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 228 in Subjects With Selected Advanced Solid Tumors
NCT02437916CI-TRIAL-00062028terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancy | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Oncology | — | UNRESOLVED | — |
| Oncology Patients | — | UNRESOLVED | — |
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 228 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AMG 228 monotherapy
- description
- Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types.
- interventionNames
- Drug: AMG 228
Primary outcomes (10)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDTran 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