Who is eligible for clinical trial NCT06263231?

Participants must meet the protocol's inclusion criteria for Sarcoma,Soft Tissue. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06263231 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

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)

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)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Intensity Therapeutics, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (21 items).

Location: USC/Norris Comprehensive Cancer Center — Los Angeles, California

Age range: 18 Years

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

Exclusion Criteria: Informed Consent:
Adult participants who lack capacity to consent without a legally authorized representative will be excluded from this study. Medical Conditions:
Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable as well as off-steroid therapy for at least 2 months.
History of severe hypersensitivity reactions to US SOC agents and vinblastine or cisplatin or other products of the same class and their excipients.
Histologically proven, unresectable, locally advanced or metastatic STS subtypes other than those specified, for example excluded subtypes include liposarcoma (well differentiated), desmoid or dermatofibrosarcoma protuberans.
Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the participant has been disease-free for at least 2 years.
Underlying medical condition that, in the investigator's opinion, will make the administration of study intervention hazardous or obscure the interpretation of toxicity determination or Adverse Events (AEs).
Concurrent medical condition requiring the use of immunosuppressive medications, or systemic corticosteroids (topical steroids are permitted); systemic corticosteroids must be discontinued at least 4 weeks prior to dosing. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if the participant is on a stable dose. Non-absorbed intra-articular steroid injections will be permitted. Use of steroids as prophylactic treatment for participants with contrast allergies to diagnostic imaging contrast dyes will be permitted.
Participants who require uninterrupted anticoagulants of any type or is on daily aspirin therapy or NSAIDS.
Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy).
Myocardial infarction within 6 months before enrollment, New York Heart Association Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing active infection or psychiatric illness/social situation that may potentially impair the participant's compliance with study procedures.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (17 Sites)

USC/Norris Comprehensive Cancer Center — Los Angeles, California
Sarcoma Oncology Center — Santa Monica, California
University of California Los Angeles (UCLA) - Santa Monica Cancer Care — Santa Monica, California
Yale School of Medicine - Smilow Cancer Hospital - Yale - New Haven Hospital Location — New Haven, Connecticut
Profound Research LLC — Farmington Hills, Michigan
Nebraska Methodist Hospital — Omaha, Nebraska
Duke Cancer Center — Durham, North Carolina
The James Cancer Hospital and Solove Research Institute — Columbus, Ohio
University of Pennsylvania - Abramson Cancer Center — Philadelphia, Pennsylvania
Temple University - Fox Chase Cancer Center — Philadelphia, Pennsylvania
Princess Margaret Cancer Centre — Toronto, Ontario
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,

📞 Contact the Study Coordinator

Phone: (203) 293-4224

Email: KGuedes@intensitytherapeutics.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗