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NCT04740034 · ClinicalTrials.gov registry record · Phase 1
A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT04740034: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT04740034 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04740034, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of AMG 340 monotherapy in subjects with mCRPC.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. A treatment-related AE (TRAE) was defined as any TEAE flagged as possibly caused by AMG 340. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs
Interventions
- DRUG AMG 340
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-04-29 |
| Est. Completion | 2024-06-24 |
| Phase | Phase 1 |
Why NCT04740034 stopped before completion
NCT04740034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which AMG 340 is the first listed.
NCT04740034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04740034 about?
NCT04740034 is a clinical study titled "A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma". This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study co...
What is the current status of trial NCT04740034?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2021-04-29. Estimated completion is 2024-06-24.
What interventions are being tested in trial NCT04740034?
The interventions under investigation include: AMG 340 (DRUG).
Who is sponsoring clinical trial NCT04740034?
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 NCT04740034's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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