Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors
Purpose
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ3370 in patients with advanced solid tumors.
Condition
- Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Phase 1 dose escalation part of the study was done sequentially. The Phase 2 part of the study will be done in parallel between the four groups.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33) |
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 8 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors |
|
|
Experimental Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33) |
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 16 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors. |
|
|
Experimental Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33) |
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 32 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors. |
|
|
Experimental Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33) |
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 58 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors. |
|
|
Experimental Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33) |
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors |
|
|
Experimental Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33) |
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors |
|
|
Experimental Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33) |
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors |
|
|
Experimental Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33) |
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors |
|
|
Experimental Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33) |
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 315 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors |
|
|
Experimental Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33) |
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors |
|
|
Experimental Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33) |
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors |
|
|
Experimental Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33) |
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors |
|
|
Experimental P2a Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33) |
20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with soft tissue sarcomas of the extremity |
|
|
Experimental P2a Group 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 days and and 250 mg/m^2/ of SQP33 for 1 day) |
10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m^2 of SQP33 infused on Day 1 and 2 with 250 mg/m^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve |
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|
Experimental P2a Group 2 (10 mL SQL70 and 250 mg/m^2/day of SQP33 for five days) |
10 mL of SQL70 injected intratumorally on Day with 250 mg/m^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve |
|
Recruiting Locations
More Details
- NCT ID
- NCT04106492
- Status
- Terminated
- Sponsor
- Shasqi, Inc.