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NCT06263231 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study of Sarcoma,Soft Tissue, sponsored by Intensity Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 333
- Enrollment target
- 17
- Study locations
NCT06263231: Active Phase 3 study of Sarcoma,Soft Tissue, sponsored by Intensity Therapeutics.
NCT06263231 is a Phase 3 study of Sarcoma,Soft Tissue that is active but no longer recruiting, run by Intensity Therapeutics. The registered enrollment target is 333 participants, above the 50-participant average among 12 other Sarcoma,Soft Tissue trials with a reported enrollment target (566% higher). The trial reports 17 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06263231, a Phase 3 study of Sarcoma,Soft Tissue, is active but no longer recruiting, sponsored by Intensity Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 333 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Eribulin
- DRUG Pazopanib
- DRUG Trabectedin
- DRUG INT230-6
Study Locations (17)
Other
- Centre Leon Berard - Lyon
- Helios Klinikum Bad Saarow - Bad Saarow
- Universitäres Krebszentrum (UCCL) - Leipzig
- Hospital de la Santa Creu i Sant Pau - Barcelona
- Hospital Universitari Vall Hebron - Barcelona
- Centro Integral Oncologico Clara Campal (HM CIOCC) - Madrid
California
- USC/Norris Comprehensive Cancer Center - Los Angeles
- Sarcoma Oncology Center - Santa Monica
- University of California Los Angeles (UCLA) - Santa Monica Cancer Care - Santa Monica
Pennsylvania
- University of Pennsylvania - Abramson Cancer Center - Philadelphia
- Temple University - Fox Chase Cancer Center - Philadelphia
Connecticut
- Yale School of Medicine - Smilow Cancer Hospital - Yale - New Haven Hospital Location - New Haven
Michigan
- Profound Research LLC - Farmington Hills
Nebraska
- Nebraska Methodist Hospital - Omaha
North Carolina
- Duke Cancer Center - Durham
Ohio
- The James Cancer Hospital and Solove Research Institute - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2024-06-28 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
What the registry record for NCT06263231 still lists
NCT06263231 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, above the 50-participant average among 12 other Sarcoma,Soft Tissue trials with a reported enrollment target (566% higher).
The record links to 1 condition, with Sarcoma,Soft Tissue appearing as the primary indexed condition, and to 4 interventions - of which Eribulin is the first listed.
NCT06263231 lists 17 locations in 9 states (Other, California, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT06263231 about?
NCT06263231 is a clinical study titled "A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)". 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 ther...
What is the current status of trial NCT06263231?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 333 participants. The study started on 2024-06-28. Estimated completion is 2028-12.
What conditions does trial NCT06263231 study?
This clinical trial studies the following conditions: Sarcoma,Soft Tissue.
What interventions are being tested in trial NCT06263231?
The interventions under investigation include: Eribulin (DRUG), Pazopanib (DRUG), Trabectedin (DRUG), INT230-6 (DRUG).
Who is sponsoring clinical trial NCT06263231?
This trial is sponsored by Intensity Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06263231 being conducted?
This trial has 17 study locations across California, Connecticut, Michigan, Nebraska, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sarcoma,Soft Tissue
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06263231's enrollment target sits among peer trials
333 1st of 12 higher than 12 of 12 other Sarcoma,Soft Tissue trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoma,Soft Tissue 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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