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NCT06263231 · ClinicalTrials.gov record · last posted 2026-08-11

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 acronym: INVINCIBLE-3
StatusRecruiting
PhasePhase 3
Started2024-06-28
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from the ClinicalTrials.gov record
To compare Overall Survival (OS) for INT230-6 vs United States (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.

Protocol amendment history 1 change detected by DataLookout

2026-08-12
Enrollment reopened
Trial Details
NCT Number NCT06263231
Lead Sponsor Intensity Therapeutics, Inc.
Collaborators: Premier Research
Conditions Sarcoma,Soft Tissue
Enrollment 333 participants
Start Date 2024-06-28
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-11