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

Phase 1: 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