NCT06263231

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

A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 333 (estimated)
• Sponsor: Intensity Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sarcoma,Soft Tissue

Interventions

Type	Name	Description
DRUG	INT230-6	INT230-6 is a fixed combination of cisplatin, vinblastine and SHAO.
DRUG	Eribulin	Eribulin IV
DRUG	Trabectedin	Trabectedin infusion
DRUG	Pazopanib	Pazopanib pill

Timeline

• Start date: 2024-06-28
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-02-16
• Last updated: 2025-07-29

Locations

17 sites across 5 countries: United States, Canada, France, Germany, Spain

Regulatory

• FDA-regulated drug study