A Phase 1b, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combination with Axitinib in Subjects with Advanced Renal Cell Carcinoma

AstraZeneca AB0 个研究点目标入组 179 人开始时间: 2024年5月17日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: AstraZeneca AB
入组人数: 179

研究概览入排标准研究者记录与标识符相似试验

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 65+（—）
性别: All

入选标准

•1. Age = 18 at the time of screening 2. Body weight > 35 kg 3. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures 4. Histologically or cytologically proven advanced RCC with clear cell component 5. Advanced RCC not previously treated in that setting 6. Provision of tumor material (= 5 unstained slides or tissue block) from an archival or fresh tissue biopsy 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Subjects must have at least 1 measurable lesion according to RECIST v1.1 9. Life expectancy = 12 weeks 10. Adequate organ and marrow function (in the absence of transfusions or growth factor support within 14 days prior to enrollment) as defined 11. Female subjects of childbearing potential: (a) Must have negative pregnancy test at screening and prior to each administration of investigational product (b) If sexually active with a nonsterilized male partner, must use at least one highly effective method of birth control from screening to 3 months (ie, 90 days; based on 5 half-lives of MEDI5752 + 6 months) after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib. 12. Female subjects must not breastfeed and must not donate, or retrieve for their own use, ova from screening to 3 months after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib. 13. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 3 months (90 days) after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib.

排除标准

•1. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results 2. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study 3. Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC or any other immune checkpoint inhibitors 4. Previous treatment with VEGF inhibitors 5. Evidence of infections as defined 6. History of organ transplant 7. Active or prior documented autoimmune or inflammatory disorders 8. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of investigational product with listed exceptions to this criterion 9. Poorly controlled blood pressure (BP), defined as BP >= 140/90 mmHg at screening and not able to be controlled prior to Cycle 1 Day 1 and any change in antihypertensive medications within 1 week prior to Cycle 1 Day 1. 10. Thromboembolic (arterial or venous) events within previous 6 months 11 Any concurrent therapy for cancer including, but not limited to, prohibited medications as listed 12 Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product 13. Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression 14. History of another primary malignancy exception 15. Major surgery within 4 weeks prior to enrollment or radiation therapy within 2 weeks prior to enrollment, or has not recovered (ie, =- Grade 1 or at baseline) from AEs due to prior treatment 16. Female subjects who are pregnant or breastfeeding as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control as described 17. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (NCI CTCAE v5.0 Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted 18. Uncontrolled intercurrent illness within the last 6 months prior to enrollment including, but not limited to, ongoing or active infection, cardiomyopathy of any etiology, symptomatic congestive heart failure (class > 2 as defined by New York Heart Association), uncontrolled hypertension, unstable angina pectoris, history of myocardial infarction, cardiac arrhythmia, interstitial lung disease, serious chronicgastrointestinal conditions associated with diarrhea 19. Uncontrolled intercurrent illness within the last 6 months prior to enrollment including psychiatric illness/social situations that would limit subject's compliance with study requirements, substantially increase subject's risk of incurring AEs or compromise subject's ability to give informed consent 20. Clinically significant gastrointestinal abnormality including: (a) Malabsorption, gastric resection, or any condition that according to investigator might affect absorption of orally taken medication (b) Active gastrointestinal bleeding in past 3 months (c) History of gastrointestinal perforation or gastrointestinal or non-gastrointestinal fistula in past 3 months 21. Serious nonhealing wound, ulcer, or bone fracture 22. Has clinically significant hemoptysis (at least 0

研究者

发起方

AstraZeneca AB

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