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 therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

Trial Details

NCT ID
NCT06263231
Phase
PHASE3
Sponsor
Intensity Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • INT230-6
  • Eribulin
  • Trabectedin
  • Pazopanib
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Santa Monica, California, United States|34.01949,-118.49138
  • Santa Monica, California, United States|34.01949,-118.49138
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Farmington Hills, Michigan, United States|42.48531,-83.37716

Key Eligibility Criteria

  • Participant is of any sex and must be ≥ 18 years old and provide written informed consent to participate in the study.
  • Type of Participant and Disease Characteristics
  • Histologically proven, unresectable, locally advanced, or metastatic Soft Tissue Sarcoma (STS) only of the following subtypes: liposarcoma (dediffe…
  • Participant must have received at least 1 line of therapy for a STS and must have progressed following anthracycline-based or alternative standard …

For full eligibility, visit ClinicalTrials.gov.

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