Ovarian Cancer Clinical Trial
Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity 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
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
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There are 10 Locations for this study
Duarte California, 91010, United States More Info
Palo Alto California, 94304, United States More Info
Santa Monica California, 90403, United States More Info
Saint Louis Missouri, 63110, United States More Info
Portland Oregon, 97239, United States More Info
Houston Texas, 77030, United States More Info
Seattle Washington, 98195, United States More Info
Camperdown New South Wales, 2050, Australia More Info
Sydney New South Wales, 2065, Australia More Info
Adelaide South Australia, 5000, Australia More Info
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