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NCT05165433 · ClinicalTrials.gov registry record · Phase 1
Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY)
A Phase 1 study of Metastatic Cancer and Epithelial Tumor, sponsored by Akamis Bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 7
- Study locations
NCT05165433: Completed Phase 1 study of Metastatic Cancer and Epithelial Tumor, sponsored by Akamis Bio.
NCT05165433 is a Phase 1 study of Metastatic Cancer and Epithelial Tumor that has completed, run by Akamis Bio. The registered enrollment target is 14 participants, below the 444-participant average among 109 other Metastatic Cancer trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05165433, a Phase 1 study of Metastatic Cancer and Epithelial Tumor, has completed, sponsored by Akamis Bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-350A in combination with pembrolizumab in patients with metastatic or advanced epithelial tumours.
Primary Outcome
Assess the safety and tolerability of NG-350A in combination with pembrolizumab by review of adverse events including serious adverse events, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.
Conditions Studied
Interventions
- BIOLOGICAL NG-350A plus Pembrolizumab
Study Locations (7)
California
- Providence Medical Foundation - Santa Monica
- UCLA - Santa Monica
Florida
- Moffitt-Advent Health Clinical Research Unit - Celebration
Pennsylvania
- Perelman Center of Advanced Medicine - Philadelphia
Texas
- MD Anderson Cancer Center - Houston
Lancashire
- The Clatterbridge Cancer Centre NHS Foundation Trust - Liverpool
Oxfordshire
- Churchill Hospital, Oxford University Hospitals NHS Foundation Trust - Oxford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-04-13 |
| Est. Completion | 2025-09-26 |
| Phase | Phase 1 |
What the finished NCT05165433 record still lists
NCT05165433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 444-participant average among 109 other Metastatic Cancer trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Metastatic Cancer appearing as the primary indexed condition, and to 1 intervention - of which NG-350A plus Pembrolizumab is the first listed.
NCT05165433 lists 7 locations in 6 states (California, Florida, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT05165433 about?
NCT05165433 is a clinical study titled "Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY)". This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-350A in combination with pembrolizumab in patients with metastatic or advanced epithelial tumours.
What is the current status of trial NCT05165433?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2022-04-13. Estimated completion is 2025-09-26.
What conditions does trial NCT05165433 study?
This clinical trial studies the following conditions: Metastatic Cancer, Epithelial Tumor.
What interventions are being tested in trial NCT05165433?
The interventions under investigation include: NG-350A plus Pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05165433?
This trial is sponsored by Akamis Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05165433 being conducted?
This trial has 7 study locations across California, Florida, Pennsylvania, Texas, Lancashire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05165433's enrollment target sits among peer trials
14 98th of 109 higher than 12 of 109 other Metastatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Cancer 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.
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