A Phase 1 Safety and Tolerability Study of KM602 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Recommended Phase 2 dose (RP2D) of KM602
研究概览
简要总结
This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and activity of KM602 as monotherapy in patients with advanced solid tumors.
详细描述
This Phase 1 study is comprised of dose escalation and expansions for KM602 monotherapy. Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.
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
- •Histologically confirmed, disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments (predominantly melanoma and non-small cell lung cancer)
- •All patients must have at least one measurable lesion at baseline according to RECIST v1.1
- •ECOG performance status of 0 or 1
- •Life expectancy of ≥ 12 weeks
- •Adequate baseline hematologic, renal, and hepatic function
排除标准
- •Patients with meningeal metastasis or symptomatic central nervous system metastasis
- •Any second malignancy active within the previous 5 years
- •Any active, known, or suspected autoimmune disease
- •Active or prior pneumonitis or interstitial lung disease
- •Prior organ allograft or allogeneic hematopoietic stem cell transplantation
- •Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 4 weeks prior to the first dose of KM602
- •Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab
- •History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
- •Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication within 14 days prior to the first dose of KM602 or during the study
- •Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C
- •Known allergies, hypersensitivity, or intolerance to KM602 or excipients in the drug product formulation
- •Active infection requiring therapy at the time of the first dose of KM602
- •Pregnancy or breastfeeding
- •Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.
研究组 & 干预措施
KM602 monotherapy
Dose escalation and expansion
干预措施: KM602 (Biological)
结局指标
主要结局
Recommended Phase 2 dose (RP2D) of KM602
时间窗: Approximately 15 months
Determined by the frequency of dose-limiting toxicities during dose-escalation
Incidence of treatment emergent adverse events
时间窗: Through study completion, approximately 28 months
Severity graded per CTCAE version 5.0
Maximum tolerated dose (MTD) of KM602, if any
时间窗: Approximately 15 months
Determined by the frequency of dose-limiting toxicities during dose-escalation
次要结局
- Anti-Drug Antibody of KM602(Through study completion, approximately 28 months)
- Disease Control Rate (DCR) of KM602(Through study completion, approximately 28 months)
- t1/2 of KM602(Through study completion, approximately 28 months)
- Plasma clearance (CL) of KM602(Through study completion, approximately 28 months)
- Objective Response Rate (ORR) of KM602(Through study completion, approximately 28 months)
- Duration of Response (DOR) of KM602(Through study completion, approximately 28 months)
- Area Under the Curve (AUC) of KM602(Through study completion, approximately 28 months)
- Progression-free survival(PFS) of KM602(Through study completion, approximately 28 months)
- Maximum Plasma Concentration (Cmax) of KM602(Through study completion, approximately 28 months)
- Volume of distribution (V) of KM602(Through study completion, approximately 28 months)
- Overall survival (OS) of KM602(Through study completion, approximately 28 months)