NCT03910530已完成1 期
A Phase 1b Study of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the Combination in Japanese Participants With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability and the pharmacokinetics (PK) of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the combination in Japanese participants with advanced solid tumor malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Participant is Japanese
- •Histologically or cytologically confirmed diagnosis of any locally advanced or metastatic solid tumors not amenable to local or other curative therapy.
- •Participants with nonevaluable lesions are allowed.
- •Life expectancy > 3 months.
- •Eastern Cooperative Oncology Group performance status 0 to
- •Female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration.
- •Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study.
- •Male participants should avoid unprotected sex with women of childbearing potential and refrain from donating sperm during participation the study.
排除标准
- •Receipt of anticancer therapy or participation in another interventional clinical study within 14 days before the first administration of study drug with the following exceptions: Immunotherapy or biological therapy (eg, monoclonal antibodies) within 21 days the first administration of study drug; 6 weeks for mitomycin-C or nitrosoureas; 7 days for tyrosine kinase inhibitors.
- •Radiotherapy within 14 days of first dose of study treatment with the following exceptions: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy that is > 30 Gy.
- •Toxicity of prior therapy and/or complications from surgical intervention that has not recovered to ≤ Grade 1 or baseline within 7 days before starting study drug treatment (with the exception of anemia not requiring transfusion support and any grade of alopecia). Note: Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
- •Receipt of prior systemic treatment with an arginase inhibitor
- •Immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy is recommended (per product label or consensus guidelines), OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).
- •Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
- •Known active central nervous system metastases and/or carcinomatous meningitis.
- •Known active hepatitis A virus, hepatitis B virus, or hepatitis C virus infection.
- •Known HIV infection.
- •Active infections requiring systemic therapy.
- •Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures and/or known hypersensitivity ≥ Grade 3, or severe reaction, to study treatments or any of their excipients or additives.
- •Participants with impaired cardiac function or clinically significant cardiac disease.
- •Evidence of interstitial lung disease or active, noninfectious pneumonitis or a history of interstitial lung disease.
- •Participant is pregnant or breastfeeding.
研究组 & 干预措施
INCMGA00012
Experimental
Single-agent INCMGA00012.
干预措施: Retifanlimab (Drug)
INCB001158 75 mg
Experimental
Single-agent INCB001158.
干预措施: INCB001158 (Drug)
INCB001158 100 mg
Experimental
Single-agent INCB001158.
干预措施: INCB001158 (Drug)
INCMGA00012 + INCB001158
Experimental
Combination of INCMGA00012 and INCB001158.
干预措施: Retifanlimab + INCB001158 (Drug)
结局指标
主要结局
Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012
时间窗: Up to approximately 2 years
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Part 2: Number of treatment-emergent adverse events in participants receiving INCB001158 in combination with INCMGA00012
时间窗: Up to approximately 2 years
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCB001158
时间窗: Up to approximately 2 years
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
次要结局
- Part 1: Cmin of single-agent INCB001158(Up to 15 days)
- Part 1: t½ of single-agent INCMGA000012(Up to 15 days)
- Part 2: t½ of INCMGA00012 and INCB001158 as a combination treatment(Up to 15 days)
- Part 1 and Part 2: Overall response rate with single-agent INCB001158(Up to 2 years)
- Part 1: Cmax of single-agent INCMGA000012(Up to 15 days)
- Part 1: Cmax of single-agent INCB001158(Up to 15 days)
- Part 1: Tmax of single-agent INCB001158(Up to 15 days)
- Part 1: Cmin of single-agent INCMGA000012(Up to 15 days)
- Part 1: AUCt of single-agent INCB001158(Up to 15 days)
- Part 1: Tmax of single-agent INCMGA000012(Up to 15 days)
- Part 1: AUCt of single-agent INCMGA000012(Up to 15 days)
- Part 2: Cmax of INCMGA00012 and INCB001158 as a combination treatment(Up to 15 days)
- Part 2: AUCt of INCMGA00012 and INCB001158 as a combination treatment(Up to 15 days)
- Part 2: Tmax of INCMGA00012 and INCB001158 as a combination treatment(Up to 15 days)
- Part 1 and Part 2: Overall response rate with INCMGA00012 in combination with INCB001158(Up to 2 years)
- Part 1 and Part 2: Disease control rate with single-agent INCMGA00012(Up to 2 years)
- Part 2: Cmin of INCMGA00012 and INCB001158 as a combination treatment(Up to 15 days)
- Part 1 and Part 2: Overall response rate with single-agent INCMGA00012(Up to 2 years)
- Part 1 and Part 2: Disease control rate with INCMGA00012 in combination with INCB001158(Up to 2 years)
- Part 1 and Part 2: Duration of response with single-agent INCMGA00012(Up to 2 years)
- Part 1 and Part 2: Duration of response with INCMGA00012 in combination with INCB001158(Up to 2 years)
- Part 1 and Part 2: Duration of response with single-agent INCB001158(Up to 2 years)
- Part 1: t½ of single-agent INCB001158(Up to 15 days)
- Part 1 and Part 2: Disease control rate with single-agent INCB001158(Up to 2 years)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)Metastatic Non-small Cell Lung CancerLocally Advanced Urothelial CancerMetastatic Urothelial CancerUnresectable MelanomaMetastatic MelanomaLocally Advanced Renal Cell CarcinomaMetastatic Clear-Cell Renal Cell CarcinomaNCT03679767Incyte Corporation121
已完成
1 期
A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid TumorsAdvanced or metastatic solid tumorsJPRN-jRCT2080224802Incyte Biosciences Japan G.K.18
进行中（未招募）
1 期
A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)Male or female, 18 years or older with histologically or cytologically confirmed diagnosis of :a. NSCLC with high PD-L1 expression (TPS = 50%) and no EGFR, ALK, or ROS activating genomic tumor aberrations.b. advanced or metastatic UC in participants who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a CPS = 10.c. unresectable or metastatic melanoma.d. advanced or metastatic RCC with clear cell component and having received no prior systemic therapyMedDRA version: 20.1Level: LLTClassification code 10080083Term: Advanced lung cancerSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10038395Term: Renal carcinomaSystem Organ Class: 100000004864EUCTR2018-002941-12-PLIncyte Corporation120
进行中（未招募）
1 期
A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)Male or female, 18 years or older with histologically or cytologically confirmed diagnosis of :a. NSCLC with high PD-L1 expression (TPS = 50%) and no EGFR, ALK, or ROS activating genomic tumor aberrations.b. advanced or metastatic UC in participants who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a CPS = 10.c. unresectable or metastatic melanoma.d. advanced or metastatic RCC with clear cell component and having received no prior systemic therapyMedDRA version: 20.1Level: LLTClassification code 10080083Term: Advanced lung cancerSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10038395Term: Renal carcinomaSystem Organ Class: 100000004864EUCTR2018-002941-12-ATIncyte Corporation120
进行中（未招募）
1 期
A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants WithSelected Solid Tumors (POD1UM-203)EUCTR2018-002941-12-ITINCYTE CORPORATIO120