Study on the Effectiveness and Safety of INT230-6 Compared to Standard Treatment in Adults with Soft Tissue Sarcomas

Inclusion Criteria

• Must be 18 years or older and able to give consent to participate.
• Have a confirmed diagnosis of certain types of soft tissue sarcoma, such as liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma, that cannot be surgically removed or has spread.
• Have tried at least one standard treatment for soft tissue sarcoma and the cancer has worsened after these treatments.
• Have no more than two previous treatments for the cancer.
• Have a tumor that can be measured and is suitable for injection.
• Be in relatively good health with an ECOG performance status of 0, 1, or 2.
• Have adequate organ function based on specific blood test results.
• Women must not be pregnant or breastfeeding and must use effective birth control if they are of childbearing potential.
• Men must agree to use contraception and not donate sperm during the study and for 90 days after.
• Must be able to understand and sign a consent form to participate.

Exclusion Criteria

• Have had brain tumors unless stable and off steroids for at least 2 months.
• Have severe allergies to certain standard treatments or their components.
• Have other types of soft tissue sarcoma not included in the study.
• Have had another cancer unless it was treated and disease-free for at least 2 years.
• Have medical conditions that could make the study treatment unsafe or affect the study results.
• Need to take immunosuppressive medications or systemic corticosteroids.
• Require continuous use of blood thinners or daily aspirin/NSAIDs.
• Have significant liver disease or active hepatitis.
• Have had a heart attack in the last 6 months or have severe heart conditions.
• Have uncontrolled illnesses like high blood pressure or diabetes.
• Have a prolonged QT interval on an ECG or a history of electrolyte imbalances.
• Are taking certain medications that affect liver enzymes or prolong the QT interval.
• Have had chemotherapy or immunotherapy within 4 weeks before starting the study.
• Have had systemic radiation therapy within 4 weeks or focal radiotherapy within 2 weeks before starting the study.
• Have used investigational drugs within 28 days before starting the study.
• Have received a live vaccine within 6 weeks before starting the study.
• Have received a COVID-19 vaccine less than 1 week before starting the study or during the study less than 3 weeks before a tumor assessment.
• Women who are pregnant or have a positive pregnancy test before treatment.