NCT06263231Phase 3Recruiting

A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)

Study sponsor: Intensity Therapeutics, Inc. · INTS

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-12Estimated

Enrollment · participants333Estimated

Source updated2026-08-11Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-08-11 · 1 field changed

Recruitment status changed

− Before

~~Active not recruiting~~

+ After

Recruiting

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Study details

Conditions studied

Sarcoma,Soft Tissue

Treatments or interventions studied

INT230-6Drug
EribulinDrug
TrabectedinDrug
PazopanibDrug

Primary outcomes · main study measures

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measure: Overall Survival (OS); description: To compare OS for INT230-6 vs US Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.; timeFrame: 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.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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