NCT05904236终止1 期
Phase 1 First-in-Human Dose Escalation and Expansion Study to Assess Safety and Tolerability of Intravenous Administration of ICVB-1042 in Patients With Advanced Solid Tumors
IconOVir Bio10 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2023年6月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 10
- 主要终点
- Safety of intravenous ICVB-1042
研究概览
简要总结
Study to evaluate the safety and tolerability of intravenous ICVB-1042
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patients with relapsed or refractory locally advanced or metastatic solid tumors who have progressed on or after at least one prior line of standard of care therapy including immune checkpoint inhibitors and targeted therapies for known molecular alterations if present
- •Measurable disease according to RECIST v1.1
- •ECOG Performance Status 0 or 1
- •Life expectancy of at least 3 months
排除标准
- •Prior SOC or other treatment with a biologic (eg, mAb) within 28 days prior to dosing or 5×half-life, whichever is longer from investigational therapy
- •Major surgical procedures within 28 days prior to dosing
- •Limited field irradiation for palliation within 14 days prior to dosing
- •Anti-viral agents, vaccinations within 28 days prior to dosing
- •Known central nervous system (CNS) metastases unless adequately treated and clinically stable without steroids for ≥14 days
- •Leptomeningeal carcinomatosis
- •Pulmonary lymphangitic spread of cancer
- •History of clinically significant cardiovascular abnormalities
- •Known active infection requiring systemic antibiotic therapy or systemic antifungal therapy
- •Known active HIV, hepatitis B or C, or other active viral disease
- •Known hematologic malignancies (requiring or not requiring active therapy).
- •Requirement for immunosuppressive therapy (ie, prednisone equivalent of >10 mg/day)
- •Women who are pregnant or lactating
- •Oxygen saturation measured with Pulse oximeter <90% and/or on supplemental O2
研究组 & 干预措施
ICVB-1042
Experimental
Part A: Dose escalation Part B: Dose expansion
干预措施: Treatment with ICVB-1042 administered intravenously (Drug)
结局指标
主要结局
Safety of intravenous ICVB-1042
时间窗: From dose administration through 12 weeks
Assessment of treatment-emergent dose limiting toxicity
次要结局
- Concentration profile of ICVB-1042 in plasma(Up to 48 hours after drug infusion)
- Determine immunogenicity of ICVB-1042(From dose administration through 12 weeks)
研究者
研究点 (10)
Loading locations...
相似试验
终止
1 期
A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid TumorsSolid TumorsNCT05996445Xencor, Inc.7
已完成
1 期
Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced MelanomaMelanomaNCT02410733BioNTech SE119
已完成
1 期
Safety and Preliminary Efficacy Study of the Antibody PAT-SM6 in Patients With Relapsed or Refractory Multiple MyelomaDrug SafetyNCT01727778Patrys Ltd.12
已完成
1 期
A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy AdultsInfluenzaNCT00851266Merck Sharp & Dohme LLC187
已完成
1 期
Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid TumorsHead and Neck Squamous Cell CarcinomaMelanoma Excluding Uveal MelanomaNon-small Cell Lung Cancer, Squamous or Non-squamousUrothelial CarcinomaRenal Cell Carcinoma, Clear CellCastration-resistant Prostate CancerOvarian Cancer, EpithelialTNBC - Triple-Negative Breast CancerColorectal CancerNCT05585034Xencor, Inc.60