NCT02318394已完成1 期
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of MEDI0562 in Adult Subjects With Selected 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
- 56
- 试验地点
- 13
- 主要终点
- Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
研究概览
简要总结
To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced solid tumors
详细描述
This is a first-time-in-human (FTiH) Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of MEDI0562 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with selected advanced solid tumors.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. Subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies.
- •Subjects must have at least 1 measurable lesion.
- •Consent to provide archived tumor specimens
- •Willingness to undergo pre-treatment and on-treatment biopsy.
- •Adequate organ function.
- •Use of highly effective contraception (females) or male condom plus spermicide (males).
排除标准
- •Prior treatment with TNFRSF agonists.
- •Subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll.
- •o Must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event.
- •History of severe allergic reactions to any unknown allergens or any components of the study drug formulations.
- •Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI
- •Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- •Unresolved toxicities from prior anticancer therapy.
- •Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
研究组 & 干预措施
Monotherapy Arm
Experimental
MEDI0562 monotherapy
干预措施: MEDI0562 (Biological)
结局指标
主要结局
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
时间窗: From time of informed consent through 12 weeks after last dose of MEDI0562
The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
次要结局
- Duration of response (DoR)(Estimated to be from time of informed consent up to 5 years)
- Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of MEDI0562 through to 30 days after last dose of investigational product)
- Disease control rate (DCR)(Estimated to be from time of informed consent up to 5 years)
- Objective response rate (ORR)(Estimated to be from time of informed consent up to 5 years)
- Maximum observed concentration (Cmax), area under the curve (AUC), clearance (CL) and terminal half-life of MEDI0562(From first dose of MEDI0562 through to 30 days after last dose of investigational product)
- Progression-free survival (PFS)(Estimated to be from time of informed consent up to 5 years)
- Induction of proliferation markers on various lymphocyte subsets, immunohistochemistry of tumor biopsies and assessment of programmed death ligand 1 (PD-L1) and tumor-infiltrating lymphocyte phenotypic markers(From time of informed consent through 12 weeks after last dose of investigational product)
- Overall survival (OS)(Estimated to be from time of informed consent up to 5 years)
研究者
研究点 (13)
Loading locations...
相似试验
终止
1 期
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus ErythematosusLupus Erythematosus, SystemicNCT01127321MedImmune LLC44
已完成
1 期
A Study to Evaluate the Safety and Tolerability of MEDI-565 in Adults With Gastrointestinal AdenocarcinomasGastrointestinal AdenocarcinomasNCT01284231MedImmune LLC78
已完成
1 期
TMC647055HPC1001 - First-in-human Trial to Examine Safety, Tolerability and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses and of Increasing Repeated Oral Doses of TMC647055 in Healthy Volunteers and in Hepatitis C Virus Infected PatientsHepatitis CNCT01202825Tibotec Pharmaceuticals, Ireland72
已完成
2 期
Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 DiabetesType 2 DiabetesNCT03645421AstraZeneca61
已完成
1 期
Study of AMG 650 in Adult Participants With Advanced Solid TumorsAdvanced Solid TumorsNCT04293094Volastra Therapeutics, Inc.66