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NCT02423902 · ClinicalTrials.gov registry record · Phase 1
A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Breast Cancer
A Phase 1 study, sponsored by Alaunos Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT02423902: Clinical Trial Phase 1 study, sponsored by Alaunos Therapeutics.
NCT02423902 is a Phase 1 study that was terminated before completion, run by Alaunos Therapeutics. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02423902, a Phase 1 study, was terminated before completion, sponsored by Alaunos Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a single-arm, phase Ib/II study to examine the safety, tolerability and preliminary efficacy of one cycle of Ad-RTS-hIL-12 immunotherapy in women with advanced breast cancer and pre-study SD or PR after completion of a minimum 12 week course of standard first- or second-line chemotherapy. The patient population will include patients with locally advanced or metastatic breast cancer of all subtypes.
Primary Outcome
Composite measure of safety and tolerability based on lab parameters, vitals, physical examination data and deaths, SAEs, and AEs resulting in patient discontinuation. Toxicity stopping rules when applicable will be determined based on a clinical assessment made by the SRC. The Sponsor conducted an additional ad hoc analysis of study-drug-related-TEAEs with an onset during the dosing period of all cycles to assess the number subjects with events of cytokine release syndrome (CRS), to include TE
Interventions
- BIOLOGICAL Ad-RTS-hIL-12
- DRUG Veledimex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2015-07-18 |
| Est. Completion | 2016-07-19 |
| Phase | Phase 1 |
Why NCT02423902 stopped before completion
NCT02423902 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Ad-RTS-hIL-12 is the first listed.
NCT02423902 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02423902 about?
NCT02423902 is a clinical study titled "A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Breast Cancer". This is a single-arm, phase Ib/II study to examine the safety, tolerability and preliminary efficacy of one cycle of Ad-RTS-hIL-12 immunotherapy in women with advanced breast cancer and pre-study SD or PR after completion of a minimum 12 week course of standard first- or second-line chemotherapy. Th...
What is the current status of trial NCT02423902?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2015-07-18. Estimated completion is 2016-07-19.
What interventions are being tested in trial NCT02423902?
The interventions under investigation include: Ad-RTS-hIL-12 (BIOLOGICAL), Veledimex (DRUG).
Who is sponsoring clinical trial NCT02423902?
This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02423902's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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