NCT04900519Unknown1 期
A Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of STI-6643, an Anti-CD47 Human Monoclonal Antibody, in Subjects With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Safety of STI-6643
研究概览
简要总结
This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.
详细描述
This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.
The study will determine an MTD and RP2D using a conventional 3+3 study design with priming dose identification (PDI) stage and therapeutic dose (TD) escalation (TDE) stage. Dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed informed consent
- •Age ≥ 18 years
- •ECOG Performance Status ≤ 2
- •Histologically- or cytologically-confirmed solid tumor
- •Patient has relapsed, is refractory to, or intolerant of standard of care therapy
- •No available approved therapy that may provide clinical benefit (per Investigator)
- •Measurable or evaluable disease by RECISTv1.14
- •Life expectancy of > 12 weeks (per Investigator)
- •Adequate laboratory parameters including:
- •Absolute neutrophil count (ANC) ≥ 1500/mm3
- •Platelets ≥ 100,000/mm3
- •Hemoglobin ≥ 12 g/dL (in the absence of transfusion over the prior 2 weeks)
- •AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
- •ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement)
- •Total bilirubin ≤ 2.0 x ULN (unless diagnosis of Gilbert's syndrome in which case < 3.0 times ULN)
- •Serum creatinine ≤ 2.0 x ULN or estimated GFR ≥ 45 mL/min (per Cockcroft- Gault equation)
- •If residual treatment related toxicity from prior therapy:
- •Treatment related toxicity resolved to ≤ Grade 1 (alopecia excepted), or
- •Treatment related toxicity resolved to ≤ Grade 2 with prior approval of the Medical Monitor
- •Willingness to comply with the study schedule and all study requirements
- •[Females] Must be postmenopausal, surgically sterile, or agree to use adequate contraception (per Investigator) throughout the study and for a least 30 days following the last dose
- •[Males] Must be surgically sterile or must agree to use adequate contraception (per Investigator) throughout the study and for at least 30 days following the last dose
- •[Males] Willingness to refrain from donating sperm throughout the study and for at least 30 days following the last dose
- •[Females] If of child-bearing potential, must have a negative serum pregnancy test
排除标准
- •Participating in any other interventional clinical study
- •Previous exposure to an anti-CD47 or SIRPα antibody
- •≤ 28 days (or 5 half-lives if shorter) between of systemic anti-tumor treatment (e.g., chemotherapy, endocrine therapy, immunotherapy, cellular therapy) and the 1st dose of STI-6643
- •≤ 28 days from prior irradiation (≤ 7 days from limited field irradiation for control of symptoms) and the 1st dose of STI-6643
- •≤ 28 days between major surgery (≤ 7 days from minor surgical procedures, no waiting period following central catheter placement)
- •≤ 7 days between administration of G-CSF, GM-CSF, erythropoietin, thrombopoietin or IL11 and the 1st dose of STI-6643
- •≤ 7 days between systemic immunosuppressive therapy in excess of 10 mg/day prednisone equivalent and the 1st dose of STI-6643 (topical or inhaled corticosteroids not restricted)
- •≤ 28 days between a live attenuated vaccine and the 1st dose of STI-6643
- •Known central nervous system (CNS) involvement with tumor (e.g., metastases, meningeal carcinomatosis)
- •Active second malignancy requiring ongoing systemic treatment
- •History of primary immunodeficiency disorders
- •History of active pulmonary tuberculosis
- •History of COVID-19 symptoms unless COVID-19 test negative ≤ 72 hours of the 1st dose of STI-6643
- •≤ 12 weeks from an allogeneic hematopoietic stem cell transplant and C1D1 or active graft-versus-host disease (GvHD)
- •Active infection (e.g., bacterial, viral, fungal) requiring systemic treatment ≤ 72 hours of the 1st dose of STI-6643
- •Known HIV-positive with CD4+ cell counts < 350 cells/uL or a history of an AIDS defining opportunistic infection
- •Known T-cell leukemia virus type 1 (HTLV1) infection, hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia
- •Significant risk for HBV reactivation (defined as HbsAg positive, HbcAb positive or HBV DNA positive)
- •Detectable HCV RNA
- •Pregnant or breast feeding
- •History of clinically significant cardiovascular abnormalities including:
- •Congestive heart failure (NYHA classification ≥ 3) within 6 months of the 1st dose of STI-6643
- •Unstable angina pectoris
- •≤ 6 months from myocardial infarction and the 1st dose of STI-6643
- •Arrhythmias (other than atrial fibrillation) requiring ongoing treatment
- •QTcF interval > 480 msec (using Fridericia's formula)
- •Uncontrolled hypertension (i.e., systolic BP > 180 mmHg or diastolic BP > 100
- •Any condition, including the presence of laboratory abnormalities, that places the subject at an unacceptable risk if the subject was to participate in the study.
研究组 & 干预措施
STI-6643
Experimental
STI-6643 will be provided in a single use 10-mL high borosilicate type 1 glass vial at a concentration of 500mg/10 mL (50 mg/mL) administered intravenously weekly for 4 weeks, then biweekly for Cycles 2 and up.
干预措施: STI-6643 (Biological)
结局指标
主要结局
Safety of STI-6643
时间窗: Baseline through study completion at up to approximately 31 months
Safety as assessed by incidence of adverse events, SAEs, DLTs, and clinically significant changes in safety lab results
次要结局
- STI-6643 receptor occupancy(Day 1 through Day 22)
- Anti-drug antibodies directed to STI-6643(Day 1 through Day 15)
- PK parameters(Day 1 through Day 22)
- Overall response rate(Day 1 through study completion at up to approximately 31 months)
- Duration of response(Day 1 through study completion at up to approximately 31 months)
研究者
研究点 (5)
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