jRCT2031230712招募中不适用
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amgen K.K.
- 入组人数
- 220
- 主要终点
- Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant has provided informed consent to the main study prior to initiation of any study specific activities/procedures
- •Male or female participants age >= 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Participants with histologically or cytologically documented selected solid tumor diseases. Participants must have exhausted available standard of care (SOC) systemic therapy or must not be candidates for such available therapy
- •For dose expansion cohorts: participants with at least 1 measurable lesion >= 10 mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study
- •Life expectancy > 3 months
- •Adequate organ function
排除标准
- •Untreated central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
- •History of other malignancy within the past 2 years
- •Ongoing or active infection (including chronic or localized)
- •Any pleural effusion or pericardial effusion within 4 weeks or ascites requiring recurrent drainage procedures or other medical intervention within 2 weeks prior to the first dose of the investigational products.
- •Known interstitial lung disease
- •Positive test for human immunodeficiency virus (HIV)
- •Positive hepatitis B surface antigen or positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR)
- •History of non-infectious/immune-checkpoint inhibitor related pneumonitis that required corticosteroids, or current or suspected pneumonitis that cannot be ruled out by imaging at screening.
- •Anticancer therapies including radiotherapy (with the exception of palliative radiation) chemotherapy or molecularly targeted treatments or tyrosine kinaseinhibitors (TKI) within 4 weeks of administration of the first dose of AMG 305; checkpoint inhibitor therapy within 3 months of the first dose of AMG 305; or other immunotherapies/monoclonal antibodies within 3 weeks of administration of the first dose of AMG
- •Has had a major surgery within 4 weeks of administration of a first dose of study treatment
- •Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study (eg, ulcerative colitis, Crohn's disease)
- •Live and/or live-attenuated vaccines received within 28 days (or longer, if required locally) prior to the first dose of AMG
- •Participants with unresolved toxicities from prior anti-tumor therapies to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 or better, with the exception of alopecia and grade 2 peripheral neuropathy, which has been unchanged within the last 2 months and there is agreement to allow by both the investigator and sponsor
- •Currently receiving treatment in another investigational device or drug study
- •Female participants of childbearing potential or male participants unwilling to use protocol specified method of contraception
- •Females who are pregnant, breastfeeding or who plan to breastfeed or become pregnant while on study
- •History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion
结局指标
主要结局
Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to a maximum of 2 years
Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.
次要结局
- Time to Progression(Up to a maximum of 2 years)
- Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)(Up to a maximum of 2 years)
- ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)(Up to a maximum of 2 years)
- Duration of Response (DOR)(Up to a maximum of 2 years)
- Progression-Free Survival (PFS)(Up to a maximum of 2 years)
研究者
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