A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)
← catalyst calendarNCT06263231 · readout ≤ 499 d
Sponsored by Intensity Therapeutics, Inc. (industry) · INTS — their whole pipeline →. With Premier Research.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
333estimated
Sites
17
Countries
Canada, France, Germany +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-06-28 | actual | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-02-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Sarcoma,Soft Tissue
Interventions
- Drug: INT230-6
- Drug: Eribulin
- Drug: Trabectedin
- Drug: Pazopanib
Primary outcome
what the primary-completion date above is the date OFOverall Survival (OS)
measured From date of randomization until the documented date of death from any cause for a period of up to 2 years, unless superiority is demonstrated sooner or 80% of deaths during the study period.
Publications
- PMID 10235518 — cited as background
- PMID 29361469 — cited as background
- PMID 32599852 — cited as background
- PMID 31646070 — cited as background
- PMID 24608201 — cited as background
- PMID 25058905 — cited as background
- PMID 26371143 — cited as background
- PMID 34303806 — cited as background
- PMID 31503332 — cited as background
- PMID 17032495 — cited as background
- PMID 30675651 — cited as background
- PMID 35830886 — cited as background
- PMID 17804698 — cited as background
- PMID 7165009 — cited as background
- PMID 11709461 — cited as background
- PMID 35444542 — cited as background
- PMID 23079473 — cited as background
- PMID 27354481 — cited as background
- PMID 12022551 — cited as background
- PMID 27748430 — cited as background
- PMID 19934295 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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