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NCT03514121 · ClinicalTrials.gov registry record · Early Phase 1
FPA150 in Patients With Advanced Solid Tumors
A Early Phase 1 study, sponsored by Five Prime Therapeutics.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 95
- Enrollment target
NCT03514121: Clinical Trial Early Phase 1 study, sponsored by Five Prime Therapeutics.
NCT03514121 is a Early Phase 1 study that was terminated before completion, run by Five Prime Therapeutics. The registered enrollment target is 95 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03514121, a Early Phase 1 study, was terminated before completion, sponsored by Five Prime Therapeutics.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of FPA150, an anti-B7H4 antibody alone or in combination with pembrolizumab an anti-PD1 antibody in patients with advanced solid tumors. The Phase 1a, open-label, cohort will identify a recommended dose of FPA150 to use for Phase 1a Combination (FPA150 and Pembrolizumab) Safety Lead-in and for Phase 1b monotherapy cohorts.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject that was administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. Grade 3 and 4 severity ratings were defined as follows: Grade 3: Severe or medically significant but non-immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; severe AE
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL FPA150
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2018-03-27 |
| Est. Completion | 2021-04-21 |
| Phase | Early Phase 1 |
Why NCT03514121 stopped before completion
NCT03514121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% higher).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03514121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03514121 about?
NCT03514121 is a clinical study titled "FPA150 in Patients With Advanced Solid Tumors". This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of FPA150, an anti-B7H4 antibody alone or in combination with pembrolizumab an anti-PD1 antibody in patients with advanced solid tumors. The Phase 1a, open-label, ...
What is the current status of trial NCT03514121?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 95 participants. The study started on 2018-03-27. Estimated completion is 2021-04-21.
What interventions are being tested in trial NCT03514121?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), FPA150 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03514121?
This trial is sponsored by Five Prime Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03514121's enrollment target sits among peer trials
95 226th of 2000 higher than 1,774 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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