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NCT04260191 · ClinicalTrials.gov registry record · Phase 1
Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT04260191: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT04260191 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04260191, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
To evaluate the safety and tolerability of AMG 910 in adult subjects, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
Primary Outcome
All DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. DLTs were defined as any AEs at least possibly related to AMG 910 with an onset within the first 28 days following first dose with any of the following: * Grade 2 gastric perforation or fistula * Grade ≥ 3 non-hematologic AEs including laboratory abnormalities * Re-challenge with AMG 910 after treatment interruption due to any stomach toxicity results in at least same stomach toxicity and is of CT
Interventions
- DRUG AMG 910
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2022-06-02 |
| Phase | Phase 1 |
Why NCT04260191 stopped before completion
NCT04260191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which AMG 910 is the first listed.
NCT04260191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04260191 about?
NCT04260191 is a clinical study titled "Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma". To evaluate the safety and tolerability of AMG 910 in adult subjects, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
What is the current status of trial NCT04260191?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2020-06-29. Estimated completion is 2022-06-02.
What interventions are being tested in trial NCT04260191?
The interventions under investigation include: AMG 910 (DRUG).
Who is sponsoring clinical trial NCT04260191?
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 NCT04260191's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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