Clinical trialNCT06263231RecruitingPhase 3Interventional

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

SponsorIntensity Therapeutics, Inc.Enrollment333Sarcoma,Soft Tissue

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Christian F. Meyer, MD, PhD, MS
Johns Hopkins University
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Albiruni Abdul Razak, MD
Recruiting

France

Centre Leon Berard
Lyon, France
Jean-Yves Blay, MD
Recruiting

Germany

Helios Klinikum Bad Saarow
Bad Saarow, Germany
Daniel Pink, MD
Recruiting
Universitäres Krebszentrum (uccl)
Leipzig, Germany
Anne-Marie Scheuble, MD
Recruiting

Spain

Hospital Universitari Vall Hebron
Barcelona, Spain
Claudia Valverde, MD
Recruiting
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
Raúl Terés Lleida, MD
Recruiting
Centro Integral Oncologico Clara Campal (hm Ciocc)
Madrid, Spain
Justo Ortega, MD
Recruiting

United States

Usc/norris Comprehensive Cancer Center
Los Angeles, California, United States
James Hu, MD
Recruiting
Sarcoma Oncology Center
Santa Monica, California, United States
Sant P Chawla, MD
Recruiting
University of California Los Angeles (ucla) - Santa Monica Cancer Care
Santa Monica, California, United States
Arun Singh, MD
Recruiting
Yale School of Medicine - Smilow Cancer Hospital - Yale - New Haven Hospital Location
New Haven, Connecticut, United States
Hari Deshpande, MD
Recruiting
Profound Research Llc
Farmington Hills, Michigan, United States
Savitha Balaraman, MD
Recruiting
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Kirsten M. Leu
Recruiting
Duke Cancer Center
Durham, North Carolina, United States
Richard Riedel, MD
Recruiting
the James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
David Liebner, MD
Recruiting
Temple University - Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Margaret Von Mehren, MD
Recruiting
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Lee Hartner, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Eribulin →INT230-6Pazopanib →Trabectedin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Jun 2024
Primary completion: 31 Dec 2027
Completion: 31 Dec 2028
Last update posted: 11 Aug 2026
Registered enrollment: 333
Registry id: NCT06263231

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.