Status:
TERMINATED
Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors
Lead Sponsor:
Shasqi, Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ3370 in patients with advanced solid tumors.
Eligibility Criteria
Inclusion
- Phase 1:
- 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2023
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04106492
Start Date
August 1 2020
End Date
September 7 2023
Last Update
November 14 2025
Active Locations (10)
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1
City of Hope
Duarte, California, United States, 91010
2
Stanford Cancer Center
Palo Alto, California, United States, 94304
3
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
4
Washington University in St. Louis
St Louis, Missouri, United States, 63110