INVINCIBLE-3: Intratumorally administered INT230-6 in advanced soft tissue sarcomas

A multicenter, randomized, phase III study to assess the efficacy and safety of intratumorally administered INT230-6 in locally recurrent, inoperable or metastatic soft tissue sarcomas.

Agents: INT230-6
Phase III
Status Open, recruiting
Sponsor Intensity Therapeutics, Inc.

 

Further information: https://www.clinicaltrials.gov/study/NCT06263231

 

WHO is the trial for?
  • Adult patients with the following subtypes of soft tissue sarcomas: liposarcoma (dedifferentiated, myxoid, round cell or pleomorphic), leiomyosarcoma (LMS), and undifferentiated pleomorphic sarcoma (UPS)
  • Patients must have had at least 1 treatment for soft tissue sarcoma (STS), with progression of disease after anthracycline-based or other standard therapies (unless contraindicated or refused).
  • No more than 2 prior treatments for unresectable, locally advanced, or metastatic STS.

WHAT is the key question that this trial is attempting to answer?

 The trial seeks to answer if INT230-6, an experimental treatment, can shrink or stabilize advanced liposarcomas, LMS or UPS when injected directly into the tumor.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN will the trial be open?

 The study is open (recruiting) for participation.

WHERE is the trial available?

 The trial is being conducted in the United States, Canada, Germany and Spain. More countries will open in due course.

For further information please check here.

STUDY DESIGN: What does the study look like?

 The study is designed to see how well INT230-6, a drug made of cisplatin, vinblastine, and SHAO, works compared to the usual treatments for LMS, liposarcomas and UPS in the U.S. Participants are randomly assigned to one of the treatment groups, and everyone knows which treatment they are getting (open-label).

Treatment Groups:

  • Experimental: INT230-6 Treatment
    INT230-6 is injected into the tumor every two weeks (± 2 days) for up to 5 sessions. After the main treatment phase, participants enter a maintenance phase lasting 22 months. In this phase, the doctor may inject more INT230-6 into the tumors every 12 weeks, depending on the tumor size.
  • Active Comparator: Standard U.S. Treatment
    Participants in this group may receive one of these treatments, depending on the type of soft tissue sarcoma they have and the doctor’s choice: Pazopanib, Trabectedin or Eribulin

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients. If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken