NCT03418532终止1 期
A Phase 1b/2, Single-arm, Open-label, Multi-center Study of MP0250 in Combination With Osimertinib in Patients With EGFR-mutated Non-squamous Non-small Cell Lung Cancer (NSCLC) Pretreated With Osimertinib
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 20
- 主要终点
- Estimate the objective response rate (ORR)
研究概览
简要总结
The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPin® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy.
MP0250 is a multi-DARPin® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease
- •Radiologically documented disease progression on previous osimertinib treatment.
- •Radiologically documented disease progression on or after most recent antitumor therapy.
- •Measurable disease according to RECIST 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0
- •Men and women ≥18 years old on the day of signing informed consent.
- •Adequate hematological, hepatic and renal function prior to first dose
- •Serum albumin concentration ≥30 g/L
- •Potassium and magnesium within normal range
排除标准
- •Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.
- •Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.
- •Known pre-existing interstitial or inflammatory lung disease.
- •Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.
- •Known brain metastases who are clinically unstable
- •Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤1
- •Any investigational drug within 28 days prior to study treatment.
- •Current participation in any other interventional clinical study (except survival follow up).
- •Neuropathy as residual toxicity after prior antitumor therapy Grade >2
- •Patients taking medications that have the potential to prolong the QT interval
- •Significant cardiac abnormalities
- •Uncontrolled hypertension
- •Significant risk for bleeding
- •Active or recent thrombolic events
结局指标
主要结局
Estimate the objective response rate (ORR)
时间窗: 6 months
Tumor response will be assessed based on RECIST 1.1 by using CT or MRI
次要结局
- duration of response (DOR)(9 months)
- time to response (TTR)(4 months)
- Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.(15 months)
- progression free survival (PFS)(12 months)
- overall survival (OS)(24 months)
- Incidence of anti-drug (MP0250) antibody formation(15 months)
- pharmacokinetics(15 months)
研究者
研究点 (20)
Loading locations...
相似试验
终止
1 期
A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.Non-small Cell Lung Cancer (NSCLC)Triple Negative Breast Cancer (TNBC)Pancreatic Ductal Adenocarcinoma (PDAC)Colorectal Cancer Microsatellite Stable (MSS)Renal Cell Carcinoma (RCC)Metastatic Castration Resistant Prostate Cancer (mCRPC)Ovarian CancerNCT03549000Novartis Pharmaceuticals127
尚未招募
1 期
A Study of B1962, a PD-L1/VEGF Bispecific Antibody Fusion Protein, for Advanced Solid TumorsNeoplasms MalignantNCT05650385Tasly Biopharmaceuticals Co., Ltd.68
进行中（未招募）
1 期
AZD9291 in Combination With Ascending Doses of Novel TherapeuticsAdvanced Non Small Cell Lung CancerNCT02143466AstraZeneca344
已完成
1 期
A Study of DZD8586 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (TAI-SHAN1)Lymphoma, Non-HodgkinNCT05844956Dizal Pharmaceuticals17
终止
1 期
Study to Assess EXS21546 in Combination in Patients With Advanced Solid TumoursAdvanced Solid TumoursNCT05920408Exscientia AI Limited6