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NCT06459869 · ClinicalTrials.gov registry record · Phase 1
NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
A Phase 1 study of Locally Advanced Rectal Cancer (LARC), sponsored by Akamis Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT06459869: Recruiting Phase 1 study of Locally Advanced Rectal Cancer (LARC), sponsored by Akamis Bio.
NCT06459869 is a Phase 1 study of Locally Advanced Rectal Cancer (LARC) that is actively recruiting participants, run by Akamis Bio. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06459869, a Phase 1 study of Locally Advanced Rectal Cancer (LARC), is actively recruiting participants, sponsored by Akamis Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
Study Summary
The FORTRESS trial (NG-350A-03) is an open-label, single-arm, and multicentre trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence.
Conditions Studied
Interventions
- RADIATION Radiotherapy
- DRUG NG-350A IV administration
- DRUG Capecitabine oral administration
Study Locations (6)
Other
- University College London NHS FT - London
- The Royal Marsden NHS Foundation Trust - Sutton
Florida
- AdventHealth Orlando - Orlando
Missouri
- Washington University School of Medicine - St Louis
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-04-07 |
| Est. Completion | 2028-11-30 |
| Phase | Phase 1 |
What NCT06459869 shows while recruiting
NCT06459869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Locally Advanced Rectal Cancer (LARC) appearing as the primary indexed condition, and to 3 interventions - of which Radiotherapy is the first listed.
NCT06459869 lists 6 locations in 5 states (Other, Florida, Missouri).
Frequently Asked Questions
What is clinical trial NCT06459869 about?
NCT06459869 is a clinical study titled "NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer". The FORTRESS trial (NG-350A-03) is an open-label, single-arm, and multicentre trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence.
What is the current status of trial NCT06459869?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-04-07. Estimated completion is 2028-11-30.
What conditions does trial NCT06459869 study?
This clinical trial studies the following conditions: Locally Advanced Rectal Cancer (LARC).
What interventions are being tested in trial NCT06459869?
The interventions under investigation include: Radiotherapy (RADIATION), NG-350A IV administration (DRUG), Capecitabine oral administration (DRUG).
Who is sponsoring clinical trial NCT06459869?
This trial is sponsored by Akamis Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06459869 being conducted?
This trial has 6 study locations across Florida, Missouri, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06459869's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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