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NCT03319459 · ClinicalTrials.gov registry record · Phase 1
FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by Fate Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT03319459: Completed Phase 1 study, sponsored by Fate Therapeutics.
NCT03319459 is a Phase 1 study that has completed, run by Fate Therapeutics. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03319459, a Phase 1 study, has completed, sponsored by Fate Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows: * Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies. * Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors. * Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.
Primary Outcome
The incidence of dose-limiting toxicity (DLT) within each dose cohort within the first 28 days after FATE-NK100 administration (ie, Day 1 through Day 29).
Interventions
- DRUG Trastuzumab
- DRUG Cetuximab
- DRUG FATE-NK100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2018-01-18 |
| Est. Completion | 2020-12-15 |
| Phase | Phase 1 |
What the finished NCT03319459 record still lists
NCT03319459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT03319459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03319459 about?
NCT03319459 is a clinical study titled "FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors". This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows: * Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies. * Regimen B: FATE-NK100 in combination with...
What is the current status of trial NCT03319459?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2018-01-18. Estimated completion is 2020-12-15.
What interventions are being tested in trial NCT03319459?
The interventions under investigation include: Trastuzumab (DRUG), Cetuximab (DRUG), FATE-NK100 (DRUG).
Who is sponsoring clinical trial NCT03319459?
This trial is sponsored by Fate Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03319459's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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