NCT04144842已完成1 期
A First-in-human, Multicenter, Open-label, Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of Intravenously Administered ATOR-1017
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
研究概览
简要总结
The aim of the study is to assess the safety and tolerability of increasing doses of ATOR-1017 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:
- •A patient is eligible to be included in the study if all the following criteria apply:
- •Has a diagnosis of advanced and/or refractory solid malignancy (histologically or cytologically documented)
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Has a minimum of one measurable tumor lesion
- •Has acceptable hematologic and clinical chemistry laboratory values
排除标准
- •A patient is excluded if any of the following criteria apply:
- •Has not recovered from AEs to at least grade 1 by CTCAE version 5.0 due to prior anti-cancer medications
- •Has symptomatic, steroid-dependent or progressive brain metastasis/metastases
- •Has a history of another primary malignancy, except for: a) Malignancy treated with curative intent and with no known active disease within 2 years prior to first dose of ATOR-1017, b) Adequately treated non-invasive basal skin cancer or squamous cell skin carcinoma, c) Adequately treated uterine cervical cancer stage 1B or less
- •Has an autoimmune disorder requiring immune modulating treatment during the last 2 years
- •Receives treatment with systemic immunosuppressant medication (except for inhaled and low dose systemic corticosteroids, i.e. ≤10 mg prednisolone or equivalent per day)
- •Is a female patient who is pregnant or nursing
研究组 & 干预措施
ATOR-1017
Experimental
ATOR-1017 administered by intravenous infusions every 3 weeks until confirmed progressive disease, clear clinical deterioration, unacceptable toxicity or withdrawal of consent
干预措施: ATOR-1017 (Biological)
结局指标
主要结局
Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
时间窗: From start of study until 28 days after last dose
Number of participants with treatment-related AEs assessed by CTCAE v 5.0
Safety and tolerability: Dose-limiting toxicities (DLTs)
时间窗: From first dose of ATOR-1017 (Day 1) until Day 21
Number of participants with DLTs
次要结局
- Pharmacokinetics: Time to Cmax(From start of study until end of study (28-56 days after last dose))
- Pharmacokinetics: Maximum observed serum concentration of ATOR-1017 (Cmax)(From start of study until end of study (28-56 days after last dose))
- Pharmacokinetics: Area under the ATOR-1017 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))
- Immunogenicity: Anti-drug antibody (ADA) titer in serum(From start of study until end of study (28-56 days after last dose))
研究者
研究点 (3)
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