A First-in-human, Multicenter, Open-label, Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of Intravenously Administered ATOR-1015
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 5
- 主要终点
- Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
研究概览
简要总结
The aim of the study is to investigate the safety and tolerability of ATOR-1015 when administered as repeated intravenous infusions to patients with advanced and/or refractory solid malignancies.
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
- •Major Inclusion Criteria:
- •Diagnosis of advanced and/or refractory solid malignancy
- •Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy of at least 3 months
排除标准
- •Organ transplant recipient
- •Active autoimmune disorder
- •Other malignancy
研究组 & 干预措施
ATOR-1015
ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent.
干预措施: ATOR-1015 (Biological)
结局指标
主要结局
Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
时间窗: From start of study until 28 days after last dose
Number of participants with treatment-related AEs assessed by CTCAE v5.0
Safety and tolerability: Vital signs
时间窗: From start of study until end of study (28-56 days after last dose)
Vital signs include blood pressure, pulse rate, oxygen saturation and body temperature. Clinically significant abnormal findings will be reported as AEs.
Safety and tolerability: Physical examination
时间窗: From start of study until end of study (28-56 days after last dose)
Physical examination will as a minimum include examination of mouth, throat, lymph nodes, respiratory, cardiovascular system, abdomen, extremities, neurological system and skin. Clinically significant abnormal findings will be reported as AEs.
Safety and tolerability: 12-lead electrocardiogram (ECG)
时间窗: From start of study until end of study (28-56 days after last dose)
Clinically significant abnormal ECG findings will be reported as AEs.
Safety and tolerability: Clinical laboratory tests
时间窗: From start of study until end of study (28-56 days after last dose)
Clinical laboratory tests include clinical chemistry, hematology, coagulation, hormones and urinalysis.
次要结局
- Immunogenicity: Anti-drug antibody (ADA) titer in serum(From start of study until end of study (28-56 days after last dose))
- Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (Cmax)(From start of study until end of study (28-56 days after last dose))
- Pharmacokinetics: Time to Cmax(From start of study until end of study (28-56 days after last dose))
- Pharmacokinetics: Area under the ATOR-1015 serum concentration-time curve (AUC)(From start of study until end of study (28-56 days after last dose))
- Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST)(From start of study until end of study (28-56 days after last dose))