NCT03448042进行中（未招募）1 期
A Phase Ia/Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Runimotamab Administered Intravenously as a Single Agent and in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 123
- 试验地点
- 54
- 主要终点
- Percentage of Participants with Adverse Events
研究概览
简要总结
This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •* Life expectancy of at least 12 weeks
- •* Adequate hematologic and end-organ function
- •* Acute, clinically significant treatment-related toxicity from prior therapy must have resolved to Grade \/=50%
- •HER2-Expressing Breast Cancer-Specific Inclusion Criteria
- •* Locally tested, Human Epidermal Growth Factor Receptor 2 (HER2)-expressing BC
- •* Locally advanced or metastatic BC that has relapsed or is refractory to established therapies
- •HER2-Expressing Gastric/Gastroesophageal (GEJ) Cancer-Specific Inclusion Criteria
- •* Adenocarcinoma of the stomach or GEJ with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy
- •* HER2-expressing tumor (primary tumor or metastasis) as assessed by local lab testing
- •* HER2-positive gastric/GEJ cancer must have received prior trastuzumab, cisplatin (or carboplatin or oxaliplatin or investigational platinum agent) and 5-fluorouracil (5-FU)/capecitabine
- •HER2-Positive Solid Tumor Specific Inclusion Criteria
- •* HER2-positive tumor (primary tumor or metastasis) as assessed by local (non-central) laboratory testing
- •* Locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care; or for whom a clinical trial of an investigational agent is considered an acceptable treatment option
排除标准
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 140 days after the last dose of runimotamab
- •Significant cardiopulmonary dysfunction
- •Known clinically significant liver disease
- •Positive for acute or chronic Hepatitis B virus (HBV) infection
- •Acute or chronic Hepatitis C virus (HCV) infection
- •Human Immunodeficiency Virus (HIV) seropositivity
- •Poorly controlled Type 2 diabetes mellitus
- •History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
- •Current treatment with medications that are well known to prolong the Q-wave/T-wave (QT) interval
- •Known clinically significant liver disease
- •Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)
- •Leptomeningeal disease
- •Spinal cord compression that has not definitively treated with surgery and/or radiation
- •History of autoimmune disease
- •Prior allogeneic stem cell or solid organ transplantation
研究组 & 干预措施
Dose Escalation
Experimental
Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD).
干预措施: Runimotamab (Drug)
Dose Escalation
Experimental
Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD).
干预措施: Trastuzumab (Drug)
Dose Expansion
Experimental
Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
干预措施: Tocilizumab (Drug)
Dose Escalation
Experimental
Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD).
干预措施: Tocilizumab (Drug)
Dose Expansion
Experimental
Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
干预措施: Runimotamab (Drug)
Dose Expansion
Experimental
Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events
时间窗: From baseline through end of study (approximately 78 months)
次要结局
- Minimum Observed Serum Concentration (Cmin) of Runimotamab(At predefined intervals from Cycle 1, Day 1 (approximately 1 year))
- Volume of Distribution at Steady State (Vss) of Runimotamab(At predefined intervals from Cycle 1, Day 1 (approximately 1 year))
- Serum Concentration of Runimotamab(At predefined intervals from Cycle 1, Day 1 (approximately 1 year))
- Objective Response (OR) as Determined by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)(Baseline through the end of study (approximately 78 months))
- Duration of Response (DOR)(From the first occurrence of a documented objective response to first documented disease progression or death from any cause, through the end of the study (approximately 78 months))
- Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab(At predefined intervals from Cycle 1, Day 1 (approximately 1 year))
- Maximum Observed Serum Concentration (Cmax) of Runimotamab(At predefined intervals from Cycle 1, Day 1 (approximately 1 year))
- Clearance (CL) of Runimotamab(At predefined intervals from Cycle 1, Day 1 (approximately 1 year))
- Anti-Drug Antibody (ADA) Levels of Runimotamab(At predefined intervals from Cycle 1, Day 1 (approximately 1 year))
研究者
研究点 (54)
Loading locations...
相似试验
Unknown
1 期
Phase I Trial to Investigate Cafusertib Hydrochloride Monotherapy in Chinese Patients With Advanced Solid TumoursNeoplasmsNCT02314884Jiangsu Hansoh Pharmaceutical Co., Ltd.40
Unknown
1 期
Phase I Clinical Study of GB222 to Evaluate the Safety, Tolerability and PK Profiles.Brain TumorNCT04178057Genor Biopharma Co., Ltd.24
终止
1 期
Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)Medical OncologyNCT02368951Bayer20
已完成
1 期
Phase I Dose Escalation of BAY1143572 in Subjects With Acute LeukemiaLeukemiaNCT02345382Bayer42
招募中
1 期
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple MyelomaRelapsed Multiple MyelomaRefractory Multiple MyelomaNCT06433947Opna Bio LLC130