NL-OMON45907已完成不适用
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 - D6060C00002
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medimmune
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Written and signed informed consent and any locally required authorization obtained from the subject/legal representative (where permissible) prior to performing any protocol-related procedures, including screening evaluations.;2. Age * 18 years at the time of study entry.;3.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 disease (including both standard of care and investigational therapies).;4. Subjects in the dose-escalation phase must have histologic documentation of advanced solid tumors, excluding primary CNS tumors and hematologic malignancies.;5. Subjects in the dose-expansion phase must have recurrent or metastatic disease for the
- •following tumor types based on treatment arm (see protocol);6. During dose escalation, subjects who have received prior therapy with regimens containing CTLA 4, PD L1, or PD 1 antagonists are permitted to enroll if all of the criteria listed in the protocol are met;7. Subjects must have at least 1 lesion that is measurable using RECIST Version 1.1 guidelines ;8. All subjects are encouraged to consent to and provide both pretreatment and on treatment tumor biopsies. If during dose escalation any dose-level cohort is expanded beyond the initial 3 to 6 subjects, the additional subjects enrolled under pharmacodynamic expansion must consent to and undergo both a pre-treatment and an on treatment tumor biopsy. ;9. ECOG Performance score of 0 or 1, with the exception of the UC cohort where an ECOG
- •performance score of 2 may be permitted
排除标准
- •1. Prior treatment with TNFRSF agonists ;2. History of severe allergic reactions to any unknown allergens or any components of the study drug formulations ;3. Active or prior documented autoimmune disease within the past 2 years. ;4. Concurrent enrollment in another clinical study.;5. Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days prior to the first dose of MEDI0562 and durvalumab or tremelimumab combination treatment; in the case of mAbs, 28 days or 5 half lives, whichever is shorter, prior to the first dose of MEDI0562 and durvalumab or tremelimumab combination treatment;6. Any concurrent chemotherapy, IMT, or biologic or hormonal therapy for cancer treatment.;7. Unresolved toxicities from prior anticancer therapy.;8. Systemic therapeutic anticoagulation or daily aspirin dose exceeding 325 mg/per day. ;9. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI0562. ;10. History of primary immunodeficiency, solid organ transplantation, or tuberculosis;11. 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 .;12. Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products ;13. Major surgery (as defined by the investigator) within 4 weeks prior to first dose of MEDI0562 ;14. Other invasive malignancy within 2 years (exception per protocol);15. Uncontrolled intercurrent illness
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