Study on SQ3370 for Patients with Advanced Solid Tumors

Inclusion Criteria

• Have been diagnosed with advanced soft tissue sarcoma or other solid tumors.
• Have good blood, liver, kidney, and blood clotting function.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a type of tumor that is known to respond to anthracycline drugs.
• Have a tumor that can be injected with the treatment.

Phase 2a Expansion Group 1 (Extremity STS):

• Have soft tissue sarcomas in the arms or legs that cannot be removed by surgery and are at least 5 cm in size.
• Have not received chemotherapy for sarcoma or radiation to the affected limb.

Phase 2a Expansion Group 2 (Unresectable STS):

• Have advanced or metastatic soft tissue sarcoma that cannot be surgically removed and can be measured.
• Have a life expectancy of more than 12 weeks.

Phase 2a Expansion Group 3a (Head and Neck):

• Have confirmed squamous-cell carcinoma of the head and neck that has either returned after treatment or was metastatic at diagnosis.
• Have received two or fewer previous treatments, which may include chemotherapy or immunotherapy.

Exclusion Criteria

• Have previously received high doses of certain chemotherapy drugs like Doxorubicin or Epirubicin.
• Have heart failure or severe heart problems.
• Have had major surgery, radiation, or certain cancer treatments recently.
• Are pregnant or breastfeeding.
• Have active cancer in the brain or spinal cord unless previously treated and stable.
• Have allergies to certain drugs or substances used in the study.
• Have uncontrolled medical conditions.

Phase 2a Expansion Group 1 (Extremity STS):

• Have uncontrolled pain from the tumor.
• Have open wounds or tissue death related to the tumor.
• Have or are at risk of compartment syndrome.

Phase 2a Expansion Group 2 (Unresectable STS):

• Have previously been treated with anthracyclines.
• Have untreated tumors in the arms or legs.

Phase 2a Expansion Group 3a (Head and Neck):

• Have a tumor blocking the airway that needs treatment.
• Have been treated with anthracyclines before.