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NCT01505153 · ClinicalTrials.gov registry record · Phase 1
Phase I Intratumoral Pbi-shRNA STMN1 LP in Advanced and/or Metastatic Cancer
A Phase 1 study, sponsored by Gradalis.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01505153: Completed Phase 1 study, sponsored by Gradalis.
NCT01505153 is a Phase 1 study that has completed, run by Gradalis. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01505153, a Phase 1 study, has completed, sponsored by Gradalis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a Phase I safety trial of bifunctional shRNA-STMN1 (pbi-shRNA™STMN1) BIV (bilamellar invaginated vesicle) lipoplex (LP), pbi-shRNA™ STMN1 LP administered by a single intratumoral (IT) injection. Patients with superficially accessible advanced cancer following prior therapies will be entered into the study following a modified dose escalation design based on the demonstrated safety of our previous clinical experience (BB-IND 13744) with the same liposome and vector DNA backbone expressing a different transgene (of which doses up to 7 mg DNA IV/single dose have been administered). Patients will accrue in 4-patient escalation cohorts using a modified Fibronacci escalation schema (100%-50%-33%-33%) at a starting intratumoral dose of 0.010 mg/kg of DNA through a dose of 0.053 mg/kg DNA intratumoral / single dose. Should a single, but not more than two (2), ≥ Grade 3 Dose Limiting Toxicity (DLT) occur in any cohort, following mandated review (see below) an additional two (2) patients will be accrued at that dose (total of six). If more than one ≥ Grade 3 toxicity occurs in any cohort, the preceding dose cohort will be expanded to six (from four) and if \< 2/6 patients experience ≥ Grade 3 toxicity, that dose will be the Phase II recommended dose. Should no ≥ Grade 3 toxicity occur in any cohort (other than Grade 3 local injection site reaction), an additional two (2) patients will be treated at 0.053 mg/kg DNA intratumoral / single dose.
Primary Outcome
To determine the safety of intratumoral administration of pbi-shRNA™ STMN1 LP in patients with superficial advanced and/or metastatic cancer who have no acceptable form of standard therapy.
Interventions
- BIOLOGICAL pbi-shRNA STMN1 LP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-02 |
| Est. Completion | 2017-04-13 |
| Phase | Phase 1 |
What the finished NCT01505153 record still lists
NCT01505153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which pbi-shRNA STMN1 LP is the first listed.
NCT01505153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01505153 about?
NCT01505153 is a clinical study titled "Phase I Intratumoral Pbi-shRNA STMN1 LP in Advanced and/or Metastatic Cancer". This is a Phase I safety trial of bifunctional shRNA-STMN1 (pbi-shRNA™STMN1) BIV (bilamellar invaginated vesicle) lipoplex (LP), pbi-shRNA™ STMN1 LP administered by a single intratumoral (IT) injection. Patients with superficially accessible advanced cancer following prior therapies will be entered ...
What is the current status of trial NCT01505153?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2012-02. Estimated completion is 2017-04-13.
What interventions are being tested in trial NCT01505153?
The interventions under investigation include: pbi-shRNA STMN1 LP (BIOLOGICAL).
Who is sponsoring clinical trial NCT01505153?
This trial is sponsored by Gradalis, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01505153's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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