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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 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. The trial reports 6 study locations across 5 states.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06459869
The ClinicalTrials.gov registry entry for NCT06459869 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akamis Bio, which has 6 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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.
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