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NCT04476797 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC
A Phase 1 study, sponsored by Galera Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT04476797: Clinical Trial Phase 1 study, sponsored by Galera Therapeutics.
NCT04476797 is a Phase 1 study that was terminated before completion, run by Galera Therapeutics. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04476797, a Phase 1 study, was terminated before completion, sponsored by Galera Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
GTI-4711-101 is a Phase I/II study of the safety of GC4711, its effect on in-field tumor response and its potential to reduce radiation-related pulmonary injury due to SBRT for lymph node negative (T1 to T3N0M0) peripheral or central localized (within 2cm of the proximal bronchial tree) NSCLC. After an open-label, Phase 1, safety cohort of 5 subjects has been completed, a randomized, placebo-controlled Phase 2 portion of 66 subjects will be conducted.
Primary Outcome
Subjects were required to have a baseline CT (chest, abdomen, and pelvis) and then were re-assessed by the same imaging modality at 6 months, 12 months, 18 months, and 24 months following the administration of GC4711/Placebo +SBRT and compared to the previous best response using RECIST 1.1 criteria.
Interventions
- DRUG GC4711 +SBRT
- DRUG Placebo +SBRT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-10-18 |
| Est. Completion | 2023-11-28 |
| Phase | Phase 1 |
Why NCT04476797 stopped before completion
NCT04476797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which GC4711 +SBRT is the first listed.
NCT04476797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04476797 about?
NCT04476797 is a clinical study titled "Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC". GTI-4711-101 is a Phase I/II study of the safety of GC4711, its effect on in-field tumor response and its potential to reduce radiation-related pulmonary injury due to SBRT for lymph node negative (T1 to T3N0M0) peripheral or central localized (within 2cm of the proximal bronchial tree) NSCLC. Afte...
What is the current status of trial NCT04476797?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2020-10-18. Estimated completion is 2023-11-28.
What interventions are being tested in trial NCT04476797?
The interventions under investigation include: GC4711 +SBRT (DRUG), Placebo +SBRT (DRUG).
Who is sponsoring clinical trial NCT04476797?
This trial is sponsored by Galera Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04476797's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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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