NCT02705482已完成1 期
A Phase 1 Multicenter, Open-label, Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 13
- 主要终点
- Safety as defined by the presence of adverse events (AE), serious adverse events (SAE), and dose limiting toxicities (DLT).
研究概览
简要总结
The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.
详细描述
This is a Phase 1 multicenter, open-label study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of MEDI0562 in combination with immune therapeutic agents in adult subjects with select 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria:
- •Written and signed informed consent.
- •Age ≥ 18 years at the time of study entry.
- •Subjects must have received and have progressed, are refractory, or are intolerant to standard therapy appropriate for the specific tumor type. Subjects should not have received more than 3 prior lines of systemic therapy for recurrent or metastatic.
- •Subjects in the dose-escalation phase, must have histologic documentation of advanced solid tumors, excluding primary CNS tumors and hematologic malignancies.
- •Subjects in the dose-expansion phase, must have recurrent or metastatic disease solid tumors according to treatment arm as specified in the protocol.
- •Subjects who have received prior therapy with regimens containing CTLA 4, PD L1, or PD 1 antagonists are permitted to enroll if additional protocol criteria are met.
- •Subjects must have at least 1 lesion that is measurable using RECIST guidelines.
- •Subjects must consent to provide archived tumor specimens for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, subjects must consent and undergo fresh tumor biopsy.
- •All subjects are encouraged to consent to and provide both pretreatment and on treatment tumor biopsies.
- •ECOG Performance score of 0 or 1, unless protocol exceptions are met.
- •In the opinion of the investigator likely to complete ≥ 8 weeks of treatment.
- •Adequate hematologic, renal and hepatic function as determined by blood laboratory values.
- •At the time of Day 1 of the study, subjects with CNS metastases must have been treated and must be asymptomatic and meet the following:
- •No concurrent treatment, inclusive of, but not limited to surgery, radiation, and/or corticosteroids
- •At least 42 days without progression of CNS metastases as evidenced by magnetic resonance imaging (MRI) or computed tomography (CT) after last day of treatment
- •At least 14 days since last dose of corticosteroids Note: Subjects with leptomeningeal disease or cord compression are excluded from the study.
- •Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must use at least 1 highly effective method of contraception from screening, and must agree to continue using such precautions for 180 days after the final dose of investigational product.
- •Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use male condom plus, if locally available, spermicide from Day 1 and for 180 days after receipt of the final dose of investigational product.
排除标准
- •Any of the following would exclude the subject from participation in the study:
- •Prior treatment with TNFRSF agonists
- •Prior treatment with IMT for certain disease types may be restricted per protocol.
- •History of severe allergic reactions to any unknown allergens or any components of the study drug formulations
- •Active or prior documented autoimmune disease within the past 2 years.
- •Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow up period of an interventional study
- •Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days prior to the first dose
- •Any concurrent chemotherapy, IMT, or biologic or hormonal therapy for cancer treatment.
- •Unresolved toxicities from prior anticancer therapy.
- •Systemic therapeutic anticoagulation or daily aspirin dose exceeding 325 mg/per day.
- •Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI0562 with exceptions as per protocol.
- •History of primary immunodeficiency, solid organ transplantation, or tuberculosis
- •Test results indicating active infection with human immunodeficiency virus (HIV) or hepatitis B or C defined by positive serologic testing and confirmatory viral nucleic acid testing
- •Pregnant or breastfeeding women
- •Major surgery within 4 weeks prior to first dose of MEDI0562 or still recovering from prior surgery.
- •Other invasive malignancy within 2 years with the exception of protocol specified criteria
- •Any uncontrolled intercurent illness or condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
研究组 & 干预措施
Arm A: MEDI0562 and durvalumab
Experimental
MEDI0562 and durvalumab
干预措施: Durvalumab (Biological)
Arm B: MEDI0562 and tremelimumab
Experimental
MEDI0562 and tremelimumab
干预措施: Tremelimumab (Biological)
Arm B: MEDI0562 and tremelimumab
Experimental
MEDI0562 and tremelimumab
干预措施: MEDI0562 (Biological)
Arm A: MEDI0562 and durvalumab
Experimental
MEDI0562 and durvalumab
干预措施: MEDI0562 (Biological)
结局指标
主要结局
Safety as defined by the presence of adverse events (AE), serious adverse events (SAE), and dose limiting toxicities (DLT).
时间窗: From time of informed consent through 12 weeks after ending treatment with investigational product
The primary endpoint is safety as assessed by presence of adverse event (AE), serious adverse event (SAE), and dose limiting toxicity (DLT).
次要结局
- Immunogenicity(At approximately 8 time points through Day 113.)
- Preliminary Antitumor Activity: Disease Control(At approximately 3 time points through Day 113.)
- Preliminary Antitumor Activity: Duration of Response(At approximately 3 time points through Day 113.)
- Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: Cmax(To be assessed at approximately 12 clinic visits through Day 113)
- Preliminary Antitumor Activity:Best Overall Response(At approximately 3 time points through Day 113.)
- Pharmacodynamic Activity(At approximately 12 time points through Day 113.)
- Preliminary Antitumor Activity: Progression-free Survival(At approximately 3 time points through Day 113.)
- Preliminary Antitumor Activity: Overall Survival(At approximately 3 time points through Day 113.)
- Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: Clearance(To be assessed at approximately 12 clinic visits through Day 113)
- Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: AUC(To be assessed at approximately 12 clinic visits through Day 113)
- Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: t½(To be assessed at approximately 12 clinic visits through Day 113)
- Preliminary Antitumor Activity: Percent Change from Baseline(At approximately 3 time points through Day 113.)
- Preliminary Antitumor Activity: Objective Response(At approximately 3 time points through Day 113.)
- Preliminary Antitumor Activity: Time to Response(At approximately 3 time points through Day 113.)
研究者
研究点 (13)
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