NCT04501276已完成1 期
A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG116, ADG116 Combined With Toripalimab (Anti-PD-1 Antibody), ADG116 Combined With ADG106 (Anti-CD137 Antibody) in Patients With Advanced/Metastatic 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
- 发起方
- Adagene Inc
- 入组人数
- 72
- 试验地点
- 5
- 主要终点
- Number of participants with adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This is a Phase 1, open-label, dose escalation study in patients with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG106, a fully human ligand-blocking agonistic anti-CD137 IgG4 mAb, is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG116 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.
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
- •Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- •≥ 18 years of age at the time of informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
- •At least 1 measurable lesion at baseline according to the definition of RECIST v1.
- •Adequate organ function.
排除标准
- •Patients who meet any of the following criteria cannot be enrolled:
- •Pregnant or breastfeeding females.
- •Childbearing potential who does not agree to the use of contraception during the treatment period..
- •Treatment with any investigational drug within washout period.
- •Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
- •Central nervous system disease involvement
- •History or risk of autoimmune disease.
- •History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 drug formulation.
- •Patients requiring systemic treatment with corticosteroids
- •Patients receiving granulocyte colony stimulating factor (G-CSF), within 14 days prior to the first dose of the study drug.
- •Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
- •Major surgery within 4 weeks prior to the first dose of the study drug.
- •Has had an allogeneic tissue/solid organ transplant.
研究组 & 干预措施
Part A : Dose escalation of ADG116 monotherapy
Experimental
干预措施: ADG116 (Drug)
Part B : Dose escalation of ADG116 combined with anti PD1 drug
Experimental
干预措施: ADG116 (Drug)
Part B : Dose escalation of ADG116 combined with anti PD1 drug
Experimental
干预措施: anti PD1 drug (Drug)
Part C : Dose escalation of ADG116 combined with ADG106
Experimental
干预措施: ADG116 (Drug)
Part C : Dose escalation of ADG116 combined with ADG106
Experimental
干预措施: ADG106 (Drug)
结局指标
主要结局
Number of participants with adverse events as assessed by CTCAE v5.0
时间窗: From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose
Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors
时间窗: From first dose of ADG116 (Week 1 Day 1) until 21 days
次要结局
- Maximum (peak) plasma concentration (Cmax)(From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years))
- Trough plasma concentration (Ctrough)(From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years))
- Incidence of ADAs(From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years))
- Preliminary evidence of antitumor activity as characterized by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), duration of stable disease, progression free survival (PFS), and overall survival (OS).(From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose)
- Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)(From first dose (Cycle 1 Day 1, ) until the last dose (up to 2 years))
- Time to maximum (peak) plasma concentration (Tmax)(From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years))
研究者
研究点 (5)
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