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NCT03058289 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
A Phase 1 study, sponsored by Intensity Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 111
- Enrollment target
NCT03058289: Completed Phase 1 study, sponsored by Intensity Therapeutics.
NCT03058289 is a Phase 1 study that has completed, run by Intensity Therapeutics. The registered enrollment target is 111 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03058289, a Phase 1 study, has completed, sponsored by Intensity Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 111 participants
- Enrollment target
Study Summary
This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the skin (breast, squamous cell, head and neck) and tumors within the body such (pancreatic, colon, liver, lung, etc.). Sponsor also tested INT230-6 in combination with anti-PD-1 and anti-CTLA-4 antibodies.
Primary Outcome
The primary objective is to assess the safety and tolerability of single and multiple intratumoral doses of INT230-6 in subjects with advanced or recurrent malignancies. This will be assessed by the rate of ≥ grade 3 AE's attributed to INT230-6 and not the underlying disease. NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 (least severe) to 5 (most severe)) All recorded adverse events will be listed and tabulated by system organ class, preferred term, and dose and co
Interventions
- DRUG INT230-6
- BIOLOGICAL anti-PD-1 antibody
- BIOLOGICAL anti-CTLA-4 antibody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2017-02-09 |
| Est. Completion | 2023-02-22 |
| Phase | Phase 1 |
What the finished NCT03058289 record still lists
NCT03058289 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher).
The record links to 0 conditions, and to 3 interventions - of which INT230-6 is the first listed.
NCT03058289 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03058289 about?
NCT03058289 is a clinical study titled "A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6". This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the skin (breast, squamous cell, head and neck) and tumors within the body ...
What is the current status of trial NCT03058289?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 111 participants. The study started on 2017-02-09. Estimated completion is 2023-02-22.
What interventions are being tested in trial NCT03058289?
The interventions under investigation include: INT230-6 (DRUG), anti-PD-1 antibody (BIOLOGICAL), anti-CTLA-4 antibody (BIOLOGICAL).
Who is sponsoring clinical trial NCT03058289?
This trial is sponsored by Intensity Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03058289's enrollment target sits among peer trials
111 512th of 2000 higher than 1,487 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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