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

Inclusion Criteria

• Diagnosis of advanced soft tissue sarcoma or other solid tumors
• Adequate hematologic, hepatic, renal, and coagulation function
• ECOG performance status score 0-1
• Tumor is the type where published clinical data would suggest that anthracyclines have cytotoxic activity
• Injectable tumor present Phase 1:

Exclusion Criteria

• Prior exposure to 300 mg/m^2 of Dox HCl or DOXIL / CAELYX ® or 600 mg/m^2 of Epirubicin HCl
• Congestive heart failure (CHF), severe myocardial insufficiency, or cardiac arrhythmia
• 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)
• Trastuzumab or trastuzumab emtansine dosed within 7 months prior to Cycle 1 Day 1.
• Any transfusion within 14 days prior to Cycle 1 Day 1.
• Pregnant or breast-feeding women.
• 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
• History of allergic reactions attributed to Dox or other anthracyclines, NaHA, hyaluronic acid, or gram-positive bacterial proteins
• History or evidence of clinically unstable/uncontrolled disorder, condition, or disease Phase 2a Expansion Group 1 (Extremity STS): Inclusion
• 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.
• High grade STS, Grade 2/3, with an assessable/injectable lesion of at least diameter ≥5 cm by RECIST 1.1 criteria
• No prior chemotherapy for STS, or radiation to affected limb Phase 2a Expansion Group 1 (Extremity STS): Exclusion
• Uncontrolled pain related to tumor
• Open wounds or tissue necrosis related to tumor mass
• Compartment syndrome or impending compartment syndrome Phase 2a Expansion Group 2 (Unresectable STS): Inclusion
• Locally advanced or metastatic, unresectable, soft-tissue sarcoma of intermediate or high grade with measurable disease.
• Life expectancy >12 weeks (about 3 month) Phase 2a Expansion Group 2 (Unresectable STS): Exclusion
• Prior exposure to anthracyclines
• Treatment naive extremity tumors Phase 2a Expansion Group 3a (Head and Neck): Inclusion
• 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
• Patients who may have received two or less systemic regimens (therapies include chemotherapy and/or immunotherapy) Phase 2a Expansion Group 3a (Head and Neck): Exclusion
• Airway obstruction by tumor mass that requires clinical intervention
• Prior treatment with anthracyclines