NCT04468607已完成1 期
A Phase I, Open-Label, Dose-Escalation Study Of The Safety And Pharmacokinetics Of BLYG8824A Administered Intravenously In Patients With Locally Advanced Or Metastatic Colorectal Cancer
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
- 46
- 试验地点
- 6
- 主要终点
- Incidence and Nature of DLTs
研究概览
简要总结
This study will evaluate the safety, tolerability, and pharmacokinetics of BLYG8824A and will make a preliminary assessment of the anti-tumor activity of BLYG8824A in patients with locally advanced or metastatic colorectal cancer.
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
盲法说明
Open Label
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
- •ECOG performance status of 0 or 1
- •Life expectancy of at least 12 weeks
- •Histologically or cytologically documented invasive CRC: incurable, unresectable, locally advanced or metastatic CRC previously treated with multimodality therapy or mCRC
- •Locally advanced or metastatic CRC that has relapsed or is refractory to established therapies
- •Prior disease progression (or intolerance) following oxaliplatin, irinotecan, fluoropyrimidines, and anti-EGFR monoclonal antibodies
- •An archival tissue specimen or fresh baseline biopsy (when archival is not available) is required for enrollment into the study
- •Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •Non-measurable evaluable disease is acceptable for dose-escalation.
- •Adequate hematologic and end organ function
- •Acute, clinically significant treatment-related toxicity from prior therapy resolved to Grade ≤ 1 prior to study entry
- •Expansion Cohort-Specific Inclusion Criteria
- •MSS or MSI-L disease as determined by polymerase chain reaction (PCR) and/or IHC
- •Measurable disease by RECIST v1.1 with at least one measurable target lesion in the expansion cohort
- •Progression must have occurred during or after most recent treatment for locally advanced or metastatic colorectal cancer
- •For patients enrolled in either a dedicated biopsy cohort or other expansion cohorts where biopsy is clinically feasible, willingness to consent to mandatory fresh pretreatment and on-treatment biopsies of safely accessible tumor lesions
排除标准
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of BLYG8824A
- •Significant cardiopulmonary dysfunction
- •Known clinically significant liver disease
- •Positive serologic or PCR test results for acute or chronic HBV infection
- •Acute or chronic HCV infection
- •HIV seropositivity
- •Poorly controlled Type 2 diabetes mellitus
- •Current treatment with medications that are well known to prolong the QT interval
- •Primary CNS malignancy, untreated CNS metastases, or active CNS metastases
- •Leptomeningeal disease
- •Spinal cord compression that has not been 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-Expansion Stage
Experimental
Once dose escalation is completed and the MTD (or MAD) has been identified, a recommended expansion dose will be proposed for the dose-expansion stage of the trial.
干预措施: BLYG8824A (Drug)
Dose-Escalation Stage
Experimental
Participants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD).
干预措施: BLYG8824A (Drug)
结局指标
主要结局
Incidence and Nature of DLTs
时间窗: Approximately 48 months
Dose Intensity
时间窗: Approximately 48 months
Number of Patricipants with Adverse Events
时间窗: Approximately 48 months
Number Of Cycles Received
时间窗: Approximately 48 months
Maximum Tolerated Dose(s) MTD(s) of BLYG8824A
时间窗: Approximately 48 months
次要结局
- Serum Concentration of BLYG8824A(At predifined interevals from Cycle 1 Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days))
- Overall Response Rate (ORR)(Approximately 48 months)
- Duration of Response (DOR)(Approximately 48 months)
- Presence of Anti-drug Antibodies (ADAs)(Cycle 1, Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days))
研究者
研究点 (6)
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