NCT05554666招募中1 期
A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASKG315 as a Single Agent in Patients With Locally Advanced or Metastatic Malignant Solid Tumors.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Dose limiting toxicities (DLTs)
研究概览
简要总结
The study is a Phase 1, open-label, multicenter, dose escalation study to evaluate the safety, tolerability, PK and PD of ASKG315 as a single agent in patients with advanced solid tumors.
详细描述
Each part of the study consists of 3 periods: screening (up to 28 days), treatment and follow-up. After an initial screening period, ASKG315 will be administered once every 3 weeks by intravenous (IV) infusion. The Part 1 dose escalation consists of 6 planned escalation cohorts, with a starting dose of 3 mg.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age.
- •Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
- •Measurable disease, per RECIST v1.
- •ECOG Performance Status of ≤
- •Life expectancy of ≥3 months, in the opinion of the Investigator.
- •Adequate organ function defined.
- •Fertile patients must be willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) during the trial and at least 90 days after the last dose;negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug or documentation of lack of childbearing potential.
- •Voluntarily enrolled and signed the informed consent form, followed the experimental treatment plan and visit arrangement.
排除标准
- •Received chemotherapy within 3 weeks prior to Cycle 1 Day 1; received radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day
- •Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day
- •Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning elective surgery during the study period.
- •Received systemic glucocorticoid or other immunosuppressant treatment within 2 weeks prior to C1D
- •Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 2 weeks prior to C1D
- •Received a live attenuated vaccine within 4 weeks prior to C1D
- •Received IL-2 or IL-15 therapy within 4 weeks prior to C1D
- •History of hematologic stem cell transplant or solid organ transplant.
- •Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤
- •Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms.
- •Serious infection requiring intravenous infusion or hospitalization, or active viral infection.
- •Current clinically significant interstitial lung disease.
- •History of serious cardiovascular or cerebrovascular diseases.
- •Active or recurrent autoimmune diseases.
- •History of Grade ≥ 3 Immune-Related Adverse Events (irAE) or Grade ≥ 2 immunotherapy-associated myocarditis associated.
- •Other malignancies within 5 years.
- •Bleeding symptoms of CTCAE 5.0 grade ≥3 within 4 weeks prior to C1D
- •Symptomatic with uncontrolled ascites or pleural effusion.
- •Hyperglycemia that cannot be stably controlled.
- •History of a grade ≥ 3 allergic reaction to protein drugs.
- •Known to have alcohol or drug dependence.
- •Severe mental disorder or poor compliance.
- •Pregnant or nursing women
- •Subjects should be excluded in the opinion of investigators.
结局指标
主要结局
Dose limiting toxicities (DLTs)
时间窗: 21days
To evaluate the safery of ASKG315 in subjects.
Adverse events(AEs)
时间窗: 21days
To evaluate the safery of ASKG315 in subjects.
次要结局
- Maximum plasma concentration (Cmax)(21days)
- Area under the concentration time curve (AUC)(21days)
- Cytokine(21days)
- Immunocyte(21days)
研究者
研究点 (4)
Loading locations...
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