Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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 40-participant average among 7 other Sarcoma,Soft Tissue trials with a reported enrollment target (733% higher). The trial reports 17 study locations across 9 states.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Sarcoma,Soft Tissue

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

FieldValue
Enrollment Target 333 participants
Start Date 2024-06-28
Est. Completion 2028-12
Phase Phase 3

Sponsor

Intensity Therapeutics

2 total trials

Interested in This Trial?

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, categorized as Phase 3. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 40-participant average among 7 other Sarcoma,Soft Tissue trials with a reported enrollment target (733% higher). The listed sponsor is Intensity Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 9 distinct geographic areas - top geographies include 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.

Explore more on PlainTrial

Sarcoma,Soft Tissue

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.