Brief Title: Phase 1 Study of SQ3370 in Patients With Advanced Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Phase 1 Cohorts

Primary Outcome 1 - Timeframe: From start of treatment to approximately 12 weeks

Primary Outcome 2 - Measure: Phase 2a Expansion Groups

Primary Outcome 2 - Timeframe: Up to 2 years

CONDITION

• C

ELIGIBILITY

Phase 1: Inclusion 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
Phase 1: Exclusion Criteria:
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
Phase 2a Expansion Group 1 (Extremity STS): Inclusion
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
Phase 2a Expansion Group 1 (Extremity STS): Exclusion
1. Uncontrolled pain related to tumor

- 2. Open wounds or tissue necrosis related to tumor mass

- 3. Compartment syndrome or impending compartment syndrome
Phase 2a Expansion Group 2 (Unresectable STS): Inclusion
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)
Phase 2a Expansion Group 2 (Unresectable STS): Exclusion
1. Prior exposure to anthracyclines

- 2. Treatment naive extremity tumors
Phase 2a Expansion Group 3a (Head and Neck): Inclusion
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)
Phase 2a Expansion Group 3a (Head and Neck): Exclusion
1. Airway obstruction by tumor mass that requires clinical intervention

- 2. Prior treatment with anthracyclines

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: J

Role: S

Affiliation: S

Overall Contact

Name: J

Phone: 4

Email: c

LOCATION