A Multicenter Phase 1/2a, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Shasqi, Inc.
- 入组人数
- 53
- 试验地点
- 10
- 主要终点
- Phase 1 Cohorts
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ3370 in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Any transfusion within 14 days prior to Cycle 1 Day
- •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
研究组 & 干预措施
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
干预措施: SQ3370 (Drug)
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.
干预措施: SQ3370 (Drug)
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.
干预措施: SQ3370 (Drug)
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.
干预措施: SQ3370 (Drug)
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
干预措施: SQ3370 (Drug)
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
干预措施: SQ3370 (Drug)
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
干预措施: SQ3370 (Drug)
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
干预措施: SQ3370 (Drug)
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
干预措施: SQ3370 (Drug)
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
干预措施: SQ3370 (Drug)
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
干预措施: SQ3370 (Drug)
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
干预措施: SQ3370 (Drug)
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
干预措施: SQ3370 (Drug)
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
干预措施: SQ3370 (Drug)
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
干预措施: SQ3370 (Drug)
结局指标
主要结局
Phase 1 Cohorts
时间窗: From start of treatment to approximately 12 weeks
To determine the Recommended Phase 2 Dose of SQ3370
次要结局
- Phase 2a: Objective Response Rate (ORR)(Up to 1 year)