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NCT03853109 · ClinicalTrials.gov registry record · Phase 1
AMG 404 in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 171
- Enrollment target
NCT03853109: Completed Phase 1 study, sponsored by Amgen.
NCT03853109 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 171 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03853109, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 171 participants
- Enrollment target
Study Summary
To evaluate the safety and tolerability of AMG 404, a monoclonal antibody that binds to PD-1 and inhibits its engagement with ligands, in patients with advanced solid tumors.
Primary Outcome
Toxicities were graded with the Common Terminology Criteria for Adverse Events CTCAE v5.0., the following toxicities were classified as DLTs: * Any treatment related grade 5 toxicity * Grade 4 neutropenia or thrombocytopenia * Febrile neutropenia * Grade 4 anemia * Grade 3 or 4 non-hematologic toxicity * Recurrent grade 2 pneumonitis * Any other toxicity requiring permanent discontinuation of AMG 404.
Interventions
- DRUG AMG 404
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2019-03-05 |
| Est. Completion | 2023-11-02 |
| Phase | Phase 1 |
What the finished NCT03853109 record still lists
NCT03853109 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher).
The record links to 0 conditions, and to 1 intervention - of which AMG 404 is the first listed.
NCT03853109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03853109 about?
NCT03853109 is a clinical study titled "AMG 404 in Patients With Advanced Solid Tumors". To evaluate the safety and tolerability of AMG 404, a monoclonal antibody that binds to PD-1 and inhibits its engagement with ligands, in patients with advanced solid tumors.
What is the current status of trial NCT03853109?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 171 participants. The study started on 2019-03-05. Estimated completion is 2023-11-02.
What interventions are being tested in trial NCT03853109?
The interventions under investigation include: AMG 404 (DRUG).
Who is sponsoring clinical trial NCT03853109?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03853109's enrollment target sits among peer trials
171 324th of 2000 higher than 1,676 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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