A phase 3 trial testing INT230-6 in sarcomas, now recruiting.
A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) is a phase 3 interventional study registered as NCT06263231, led by Intensity Therapeutics with Premier Research, and recruiting on the registry. Official title: A Multicenter, Randomised, 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). Planned enrolment is 333 participants (estimated). The study started in 2024-06-28 and primary completion is expected in 2027-12. No results have been posted on ClinicalTrials.gov.