A Phase I/II Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 99
- 主要终点
- Number of Participants with Dose Limiting Toxicity (DLT)
研究概览
简要总结
The purpose of this study is to determine the optimal dose of ARGX-110 in participants with advanced malignancies and to assess efficacy of ARGX-110 (exploratory efficacy cohort 5 only).
详细描述
Phase I study conducted in participants whose tumors express the target of interest. Pharmacokinetics (PK), pharmacodynamics (PD), biomarkers will be determined to support dose selection.
Phase II study conducted in Cutaneous T-cell lymphoma (CTCL) participants who are CD70 positive. PK, PD, biomarkers and immunohistochemistry (IHC) will be determined to assess efficacy.
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
- •Histological diagnosis of malignancy refractory to, or relapsing after standard therapy
- •Solid tumors or T-cell malignancies positive for the CD70 antigen by Immunohistochemistry/Fluorescence-activated cell sorting (IHC/FACS) within 56 days prior to administering the first dose of ARGX-
- •IHC criterion: greater than > 10 percent (%) of CD70 positive tumor cells
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or 2
- •Serum albumin greater than or equal to (>=) 20 gram per liter (g/L) (solid tumor only)
- •Ability to comply with protocol-specified procedures/evaluations and scheduled visits. In particular, the ability of the patient to undergo a tumor biopsy (optional for safety expansion cohort 4)
排除标准
- •History or clinical evidence of neoplastic central nervous system (CNS) involvement
- •History of another primary malignancy that has not been in remission for at least 1 year
- •Systemic glucocorticoid administration at doses greater than physiological replacement (prednisolone 20 milligram [mg] equivalent) within 28 days of ARGX-110 first dose administration (for T-cell malignancies higher systemic dose can be allowed following discussion with Sponsor)
- •Major surgery within 28 days of ARGX-110 first dose administration
- •Unresolved grade 3 or 4 toxicity from prior therapy, including experimental therapy
研究组 & 干预措施
Dose Escalation: Cohort 1
Participants will receive ARGX-110 as an intravenous infusion (IV) at dose level 1.
干预措施: ARGX-110 (Drug)
Dose Escalation: Cohort 2
Participants will receive ARGX-110 as an IV infusion at dose level 2.
干预措施: ARGX-110 (Drug)
Dose Escalation: Cohort 3
Participants will receive ARGX-110 as an IV infusion at dose level 3.
干预措施: ARGX-110 (Drug)
Dose Escalation: Cohort 4
Participants will receive ARGX-110 as an IV infusion at dose level 4.
干预措施: ARGX-110 (Drug)
Dose Escalation: Cohort 5
Participants will receive ARGX-110 as an IV infusion at intermediate dose level at the conclusion of Cohort 4 prior to opening the safety expansion cohorts to participants enrolment.
干预措施: ARGX-110 (Drug)
Safety Expansion: Cohort 1
Participants with solid tumors will receive ARGX-110 as an IV infusion at a dose based on the safety, PD, and PK profiles of ARGX-110 as per the dose escalation part of the trial.
干预措施: ARGX-110 (Drug)
Safety Expansion: Cohort 2
Participants with hematological malignancies (all etiologies) will receive ARGX-110 as an IV infusion at a dose based on the safety, PD, and PK profiles of ARGX-110 as per the dose escalation part of the trial.
干预措施: ARGX-110 (Drug)
Safety Expansion: Cohort 3
Participants with cutaneous T-cell lymphoma (CTCL) will receive ARGX-110 as an IV infusion at dose level 2 followed by a maintenance therapy at dose level 2 or 3.
干预措施: ARGX-110 (Drug)
Safety Expansion: Cohort 4
Participants with peripheral T-cell lymphoma (PTCL) will receive ARGX-110 as an IV infusion at dose level 2 followed by a maintenance therapy at dose level 2 or 3.
干预措施: ARGX-110 (Drug)
Exploratory Efficacy: Cohort 5
Participants with relapsed/refractory CTCL will receive ARGX-110 as an IV infusion followed by a maintenance therapy at dose level 3.
干预措施: ARGX-110 (Drug)
结局指标
主要结局
Number of Participants with Dose Limiting Toxicity (DLT)
时间窗: 21 days
DLT is defined as drug-related grade 3 or 4 clinical adverse event (AE) occurring during the 21 days (3 weeks) following the first dose of ARGX-110.
次要结局
- Biomarkers (CD70 qPCR and sCD27) of ARGX-110 biological activity(Up to 2 years)
- Number of Participants who Achieve a Tumor Response(Up to 2 years)
- Plasma Concentrations of ARGX-110(Up to 2 years)