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A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)
NCT06263231 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06263231
The ClinicalTrials.gov registry entry for NCT06263231 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intensity Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06263231 reports 17 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06263231?
The interventions under investigation include: Eribulin (DRUG), Pazopanib (DRUG), Trabectedin (DRUG), INT230-6 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06263231?
This trial is sponsored by Intensity Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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