NCT05025085
已完成
1 期
A Phase 1 Study Investigating AGEN1777 as a Single-Agent and in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors
概览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Agenus Inc.
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor
概览
简要总结
This study is a multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AGEN1777 as a single agent and when used in combination with a PD-1 inhibitor in participants with advanced, metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumor for which no acceptable standard therapy available or progressed on or after standard therapies.
- •Measurable disease on baseline imaging based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
- •Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
排除标准
- •Active infection requiring treatment.
- •Lack of recovery for participants who had major surgical procedure within 4 weeks prior to first dose of protocol therapy.
- •Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.
- •Corrected QT interval (QTc) (corrected for heart rate using Fridericia's formula prolongation) \>480 msec at screening except for right bundle branch block.
研究组 & 干预措施
Monotherapy with AGEN1777
Experimental
3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days [3 weeks]).
干预措施: AGEN1777 (Drug)
AGEN1777 in combination with a PD-1 inhibitor
Experimental
3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days.
干预措施: AGEN1777 (Drug)
AGEN1777 in combination with a PD-1 inhibitor
Experimental
3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days.
干预措施: a PD-1 inhibitor (Drug)
结局指标
主要结局
Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor
时间窗: Day 1 through Day 21
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 2 years and 90 days
次要结局
- Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor(Day 1 Up to End of Treatment (up to 2 years))
- Serum AGEN1777 Anti-Drug Antibody (ADA) Determination(Day 1 of Cycle 1 (Cycle = 21 days) through Day 1 of Cycle 5. Incidence of ADA)
- Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination(Day 1 Up to End of Treatment (up to 2 years))
- Partial Response (PR) per RECIST v1.1 Based on Investigator's Assessment(From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity)
- Complete Response (CR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Based on Investigator's assessment(From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity)
- Duration of Response (DOR) per RECIST v1.1 Based on Investigator's Assessment(From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity.)
- Stable Disease (SD) per RECIST v1.1 Based on Investigator's Assessment(From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity.)
研究者
研究点 (11)
Loading locations...
相似试验
进行中（未招募）
1 期
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced CancerAdvanced CancerAngiosarcomaColorectal Cancer Without Liver MetastasesEndometrial CancerFibrolamellar CarcinomaNon-small-cell Lung CancerOvarian CancerProstate CancerNCT03860272Agenus Inc.499
已完成
1 期
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced CancerAdvanced CancerNCT04121676Agenus Inc.91
已完成
1 期
Study of AGEN1571 in Participants With Advanced Solid TumorsAdvanced Solid TumorNCT05377528Agenus Inc.22
招募中
早期 1 期
APG-2575 Study of Safety, Tolerability ,PK/PD in Patients With Hematologic MalignanciesHematologic MalignanciesNCT03537482Ascentage Pharma Group Inc.90
已完成
1 期
Phase I Study in Healthy Male Subjects Comparing QGC001 to PlaceboEssential HypertensionNCT01900171Quantum Genomics SA56