Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors

Eligibility Criteria

• 1. Diagnosis of advanced soft tissue sarcoma or other solid tumors
• 2. Adequate hematologic, hepatic, renal, and coagulation function
• 3. ECOG performance status score 0-1
• 4. Tumor is the type where published clinical data would suggest that anthracyclines have cytotoxic activity
• 5. Injectable tumor present
• 1. Prior exposure to 300 mg/m\^2 of Dox HCl or DOXIL / CAELYX ® or 600 mg/m\^2 of Epirubicin HCl
• 2. Congestive heart failure (CHF), severe myocardial insufficiency, or cardiac arrhythmia
• 3. Any of the following within 28 days prior to Cycle 1 Day 1:
• * Major surgery, as defined by the Investigator
• * Radiotherapy
• * Chemotherapy, immunotherapy and/or anticancer therapy (except for small molecule kinase inhibitors, which are 6 elimination half-lives)
• 4. Trastuzumab or trastuzumab emtansine dosed within 7 months prior to Cycle 1 Day 1.
• 5. Any transfusion within 14 days prior to Cycle 1 Day 1.
• 6. Pregnant or breast-feeding women.
• 7. Known active CNS metastases and/or carcinomatous meningitis or symptomatic brain metastasis. Participants with previously treated brain metastases may participate provided they are radiologically stable
• 8. History of allergic reactions attributed to Dox or other anthracyclines, NaHA, hyaluronic acid, or gram-positive bacterial proteins
• 9. History or evidence of clinically unstable/uncontrolled disorder, condition, or disease
• 1. Patients with unresectable soft tissue sarcomas of the extremity AJCC Stage III OR select IV (=\>5 cm injectable tumors) locally advanced and or metastatic, not amendable to primary surgical intervention according to the consensus of a multidisciplinary treatment team, determined prior to screening.
• 2. High grade STS, Grade 2/3, with an assessable/injectable lesion of at least diameter ≥5 cm by RECIST 1.1 criteria
• 3. No prior chemotherapy for STS, or radiation to affected limb
• 1. Uncontrolled pain related to tumor
• 2. Open wounds or tissue necrosis related to tumor mass
• 3. Compartment syndrome or impending compartment syndrome
• 1. Locally advanced or metastatic, unresectable, soft-tissue sarcoma of intermediate or high grade with measurable disease.
• 2. Life expectancy \>12 weeks (about 3 month)
• 1. Prior exposure to anthracyclines
• 2. Treatment naive extremity tumors
• 1. Patients with histologically or cytologically confirmed squamous-cell carcinoma of the head and neck (HNSCC) who meet any of the following a) confirmed relapsed HNSCC or b) metastatic at initial presentation HNSCC
• 2. Patients who may have received two or less systemic regimens (therapies include chemotherapy and/or immunotherapy)
• 1. Airway obstruction by tumor mass that requires clinical intervention
• 2. Prior treatment with anthracyclines