Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors
Trial ID or NCT#
Status
Purpose
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ3370 in patients with advanced solid tumors.
Official Title
A Multicenter Phase 1/2a, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors
Eligibility Criteria
- 1. Diagnosis of advanced soft tissue sarcoma or other solid tumors2. Adequate hematologic, hepatic, renal, and coagulation function3. ECOG performance status score 0-14. Tumor is the type where published clinical data would suggest that anthracyclines have cytotoxic activity5. Injectable tumor present
- Phase 1:
- 1. Prior exposure to 300 mg/m\^2 of Dox HCl or DOXIL / CAELYX ® or 600 mg/m\^2 of Epirubicin HCl2. Congestive heart failure (CHF), severe myocardial insufficiency, or cardiac arrhythmia3. 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 stable8. History of allergic reactions attributed to Dox or other anthracyclines, NaHA, hyaluronic acid, or gram-positive bacterial proteins9. 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 criteria3. No prior chemotherapy for STS, or radiation to affected limb
- Phase 2a Expansion Group 1 (Extremity STS): Exclusion
- Phase 2a Expansion Group 2 (Unresectable STS): Inclusion
- Phase 2a Expansion Group 2 (Unresectable STS): Exclusion
- Phase 2a Expansion Group 3a (Head and Neck): Inclusion
- Phase 2a Expansion Group 3a (Head and Neck): Exclusion
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Amir Emami
650-498-0623
View on ClinicalTrials.gov