An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 22
- 主要终点
- DLT
研究概览
简要总结
This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors
详细描述
This is a Phase I, multi-center, open-label, dose-finding study of ATG-022 in patients with advanced solid tumours. The study design includes a Dose Escalation Phase which will enroll subjects with advanced/metastatic solid tumors, and a Dose Expansion Phase which will enroll select advanced/metastatic solid tumors with Claudin 18.2-positive expression at the defined maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) to further evaluate the safety, tolerability, and efficacy of ATG-022.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
- •Aged at least 18 years as of the date of consent.
- •Histological or cytological confirmation of a solid tumor, and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or not applicable for standard therapy(ies).
- •Dose Escalation Phase: all solid tumors.
- •Dose Expansion Phase: Claudin 18.2 positive solid tumors.
- •Subjects should be willing to receive a biopsy at screening, if no former available tumor tissue samples within 36 months prior to participating in the study are provided.
- •At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.
- •Estimated life expectancy of a minimum of 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 .
- •Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding, and must have a negative pregnancy test prior to the start of dosing if of child-bearing potential or must have evidence of nonchild-bearing potential by fulfilling one of the following criteria at screening
- •Male subjects should be willing to use effective contraception, ie condoms, for the duration of the study and 180 days after the final dose of study treatment.
排除标准
- •Primary central nervous system disease or central nervous system metastatic disease.
- •Prior exposure to a Claudin 18.2 targeting agent.
- •Prior therapy with any chemotherapy, immunotherapy, anticancer agents, or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (eg, a period of 5 'half-lives'.
- •Prior vaccination within 28 days of the first dose of study therapy.
- •Prior any solid organ transplant. Autologous stem cell transplant or CAR-T cell infusion < 6 months prior to the first dose of study treatment.
- •Active infection including hepatitis B, and/or hepatitis C.
- •Known history of human immunodeficiency virus (HIV) infection.
- •Any unresolved toxicities from prior therapy greater than Grade 1 at the time of ICF signature, with the exception of alopecia.
- •Pregnant or nursing females.
- •History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-
- •Other primary malignancies developed within 5 years prior to the first dose of the study drug, except locally curable malignancies after radical treatment .
- •In the opinion of the investigator, subject's complications, or other conditions (psychological, familial, sociological, or geographical etc.) may affect protocol compliance or may be unsuitable for participation in the study.
研究组 & 干预措施
ATG-022
Dose Escalation Phase:
for subjects with solid tumors,approximately 16-36 subjects will be enrolled .
Dose Expansion Phase:
The tumor types in the Dose Expansion Phase may involve other tumor types based on the signals from the Dose Escalation Phase. The total number of patients in dose expansion will be up to approximately 120 patients.
干预措施: ATG-022 (Drug)
结局指标
主要结局
DLT
时间窗: Up to 21 Days
Number of Participants with Dose Limiting Toxicity
MTD
时间窗: Up to 21 Days
Maximum Tolerated Dose
RP2D
时间窗: Up to 21 Days
RP2D= Recommended Phase 2 Dose
次要结局
- PFS(12 months after the last subject enrolled)
- ORR(12 months after the last subject enrolled)
- DOR(12 months after the last subject enrolled)