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NCT01337505 · ClinicalTrials.gov registry record · Phase 1
Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by ImmunityBio.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01337505: Completed Phase 1 study, sponsored by ImmunityBio.
NCT01337505 is a Phase 1 study that has completed, run by ImmunityBio. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01337505, a Phase 1 study, has completed, sponsored by ImmunityBio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on Day 1 every 21 days for up to 6 cycles.
Primary Outcome
Safety will be based on adverse events, tolerability, physical examinations, vital signs, ECG results, laboratory test results. MTD: If 2 of 5 subjects an any dose level experiences a grade 3 or 4 non-hematologic toxicity, or a platelet count \<25,000/uL or a neutrophil count \<500/uL lasting \>7 days and/or associated with fever \>38.5C, 3 more subjects will be entered at that dose level. If 2 of 3 of the additional subjects experience any of the above adverse events, the dose level immediately
Interventions
- DRUG INNO-206
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT01337505 record still lists
NCT01337505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which INNO-206 is the first listed.
NCT01337505 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01337505 about?
NCT01337505 is a clinical study titled "Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors". This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on Day 1 every 21 day...
What is the current status of trial NCT01337505?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-04. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01337505?
The interventions under investigation include: INNO-206 (DRUG).
Who is sponsoring clinical trial NCT01337505?
This trial is sponsored by ImmunityBio, which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01337505's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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