2023-509604-15-00进行中（未招募）1 期
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
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
- 试验地点
- 12
- 主要终点
- "Safety • Incidence of adverse events (AEs)/serious adverse events (SAEs) • Dose-limiting toxicities (DLTs) • AEs leading to discontinuation of treatment • Abnormal laboratory parameters, vital signs, electrocardiogram (ECG) results Efficacy • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1"
研究概览
简要总结
Safety: • Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of MEDI5752 combined with lenvatinib (Dose-exploration Phase) • Assess safety and tolerability of MEDI5752 combined with lenvatinib (or axitinib)
Efficacy: Assess the antitumor activity of MEDI5752 combined with lenvatinib"
详细描述
The purpose of this Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of MEDI5752 in combination with Lenvatinib (or Axitinib) in subjects with advanced renal cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- A Phase 1b, Open-label Study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 at the time of screening
- •Body weight > 35 kg
- •Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures
- •Histologically or cytologically proven advanced RCC with clear cell component
- •Advanced RCC not previously treated in that setting
- •Provision of tumor material (≥ 5 unstained slides or tissue block) from an archival or fresh tissue biopsy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Subjects must have at least 1 measurable lesion according to RECIST v1.1
- •Life expectancy ≥ 12 weeks
- •Adequate organ and marrow function (in the absence of transfusions or growth factor support within 14 days prior to enrollment) as defined
- •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.
- •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.
- •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
- •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
- •Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
- •Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC or any other immune checkpoint inhibitors
- •Previous treatment with VEGF inhibitors
- •Evidence of infections as defined
- •History of organ transplant
- •Active or prior documented autoimmune or inflammatory disorders
- •Current or prior use of immunosuppressive medication within 14 days prior to the first dose of investigational product with listed exceptions to this criterion
- •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
- •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
- •Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression
- •History of another primary malignancy exception
- •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
- •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
- •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
- •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
- •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
- •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
- •Serious nonhealing wound, ulcer, or bone fracture
- •Has clinically significant hemoptysis (at least 0.5 teaspoon of bright red blood) or tumor bleeding within 2 weeks before the first dose of investigational product.
- •Radiographic evidence of major blood vessel invasion/infiltration/encasement"
研究组 & 干预措施
volrustomig
Experimental
Participants receiving volrustomig
干预措施: volrustomig (Drug)
结局指标
主要结局
"Safety • Incidence of adverse events (AEs)/serious adverse events (SAEs) • Dose-limiting toxicities (DLTs) • AEs leading to discontinuation of treatment • Abnormal laboratory parameters, vital signs, electrocardiogram (ECG) results Efficacy • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1"
"Safety • Incidence of adverse events (AEs)/serious adverse events (SAEs) • Dose-limiting toxicities (DLTs) • AEs leading to discontinuation of treatment • Abnormal laboratory parameters, vital signs, electrocardiogram (ECG) results Efficacy • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1"
次要结局
- "Efficacy • Progression-free survival (PFS), best overall response (BOR), disease control rate (DCR), duration of response (DoR), and time to response (TTR) per RECIST v1.1 Pharmacokinetics • Concentration of MEDI5752 in serum Immunogenicity • Incidence of antidrug antibodies (ADAs) against MEDI5752 in serum "
研究者
AstraZeneca Study Information Center
Scientific
AstraZeneca AB
研究点 (12)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in ChildrenPhiladelphia ChromosomeAcute Lymphoblastic LeukemiaNCT00287105Rennes University Hospital49
已完成
2 期
Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004)Advanced MelanomaNCT03776136Merck Sharp & Dohme LLC103
已完成
1 期
Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell LymphomasRelapsed/Refractory Aggressive B-cell LymphomasNCT02271945MedImmune LLC10
已完成
1 期
Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast CancerMetastatic Breast CancerNCT01044485Centre Georges Francois Leclerc17
已完成
1 期
A Study of LVGN6051 Combined With Anlotinib in Patient With Soft Tissue SarcomaSoft Tissue SarcomaNCT05301764Lyvgen Biopharma Holdings Limited39