NCT05800964已完成1 期
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 37
- 试验地点
- 27
- 主要终点
- Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The primary objective of this study is to:
- Evaluate the safety and tolerability of AMG 305 in adult participants
- Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose
- Determine the recommended phase 2 dose (RP2D)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 kinase inhibitors (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 305
- •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
研究组 & 干预措施
Part A: Dose Exploration
Experimental
Participants will receive escalating doses of AMG 305.
干预措施: AMG 305 (Drug)
Part B: Dose Expansion
Experimental
Participants with selected solid tumors will receive the RP2D identified in Part A.
干预措施: AMG 305 (Drug)
结局指标
主要结局
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)
时间窗: Day 1 to Day 28
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.
Percentage of Participants who Experience Treatment-Related Adverse Events
时间窗: Up to a maximum of 2 years
次要结局
- Duration of Response (DOR)(Up to a maximum of 2 years)
- Time to Progression(Up to a maximum of 2 years)
- Minimum Serum Concentration (Cmin) of AMG 305(Up to a maximum of 2 years)
- Area Under the Concentration-Time Curve (AUC) of AMG 305(Up to a maximum of 2 years)
- Progression-Free Survival (PFS)(Up to a maximum of 2 years)
- Overall Survival (OS) at 1 Year(1 year)
- Maximum Serum Concentration (Cmax) of AMG 305(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)
- OS at 2 Years(2 years)
- ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)(Up to a maximum of 2 years)
研究者
研究点 (27)
Loading locations...
相似试验
已完成
1 期
A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid TumorsAdvanced Solid TumorsNCT06131398Amgen77
终止
1 期
A Phase 1 Study of AMG 330 in Subjects With Myeloid MalignanciesRelapsed/Refractory AMLMinimal Residual Disease Positive AMLMyelodysplastic SyndromeNCT02520427Amgen95
终止
1 期
Study of AMG 330 in Combination With Pembrolizumab in Adult With Relapsed or Refractory Acute Myeloid LeukemiaRelapsed or Refractory Acute Myeloid LeukemiaNCT04478695Amgen1
终止
1 期
A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor IndicationsNon-squamous Non-small Cell Lung CancerClaudin 6-positive Advanced/Metastatic Malignant Solid TumorsEpithelial Ovarian CancerNCT05317078Amgen3
已完成
1 期
Study of AMG 256 in Adult Subjects With Advanced Solid TumorsAdvanced Solid TumorsNCT04362748Amgen34