NCT05653284已完成1 期
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AK130 (TIGIT/TGF-β Bifunctional Fusion Protein) in Patients With Advanced Malignant Tumors
Akeso1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2023年2月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of participants with DLTs
研究概览
简要总结
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AK130 (TIGIT/TGF-β bifunctional fusion protein) in patients with advanced malignant tumors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written and signed informed consent and any locally required authorization obtained from the subject/legal representative.
- •Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or
- •Life expectancy ≥3 months.
- •Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
- •Subject must have at least one measurable lesion according to RECIST Version1.
- •Adequate organ function.
排除标准
- •Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.
- •Receipt of any anti-TIGIT, anti-TGF-β treatment.
- •Experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening, required the use of additional immunosuppression other than corticosteroids.
- •Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1，or to levels dictated in the inclusion/exclusion criteria, except toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
- •Major surgical procedure within 4 weeks prior to the first dose of AK130 or still recovering from prior surgery.
- •History of organ transplant.
- •Known allergy or reaction to any component of the AK130 formulation. History of severe hypersensitivity reactions to other mAbs.
研究组 & 干预措施
AK130
Experimental
Each subject will receive a single dose of AK130 every 3-week cycle (Q3W) or every 2-week cycle (Q2W). Participants may continue on study drug until unacceptable toxicity, or other withdrawal criteria is met.
干预措施: AK130 (Drug)
结局指标
主要结局
Number of participants with DLTs
时间窗: During the first four weeks of treatment with AK130
Incidence and severity of participants with adverse events (AEs)
时间窗: From time ICF is signed until 90 days after last dose of AK130
次要结局
- Duration of Response (DOR)(Up to approximately 2 years)
- Objective response rate (ORR)(Up to approximately 2 years)
- Progression-free survival (PFS)(Up to approximately 2 years)
- Time to response (TTR)(Up to approximately 2 years)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of study drug through 30 days after last dose of study drug)
- Disease control rate (DCR)(Up to approximately 2 years)
- Maximum observed concentration (Cmax) of AK130(From first dose of study drug through end of treatment (up to approximately 2 years))
- Minimum observed concentration(Cmin) of AK130(From first dose of study drug through end of treatment (up to approximately 2 years))
- Overall survival (OS)(Up to approximately 2 years)
- Area under the curve (AUC) of AK130 for assessment of pharmacokinetics(From first dose of study drug through end of treatment (up to approximately 2 years))
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant TumorsAdvanced Malignant TumorsNCT06691360Akeso87
进行中（未招募）
1 期
A Study of FDA018-ADC in Patients With Advanced Solid TumorsAdvanced/ Metastatic Solid TumorsNCT05174637Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.78
已完成
1 期
The Recombinant Humanized Anti-TIGIT Monoclonal Antibody (JS006) Monotherapy and in Combination With Toripalimab in Patients With Advanced TumorAdvanced TumorsNCT05061628Shanghai Junshi Bioscience Co., Ltd.47
终止
1 期
A Phase I Study of RGT-264 in Subjects With Advanced Solid TumorsAdvanced Solid TumorNCT05764915Regor Pharmaceuticals Inc.11
招募中
1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668Advanced Solid TumorNCT05341570Betta Pharmaceuticals Co., Ltd.60