A Phase I , Open Label, Multi-center Study to Assess the Safety and Tolerability of KGX101 Mono and Combo Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 3
- 主要终点
- Numbers of participants with adverse events
研究概览
简要总结
This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine recommended phase 2 dose of KGX101 mono and combo with envafolimab. Participants will: 1. Take drug KGX101 mono or combo with envafolimab every 3 weeks; 2. Visit the clinic for checkups and tests. Schedule will be about 6-8 times in the first month and then about every 3 weeks afterwards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard of care, no further standard can be used, or standard of care is not fit;
- •Eastern cooperative oncology grous performance status of 0-1;
- •Has at least 1 measurable lesion per RECIST 1.1;
- •Has adequate organ and bone marrow function as per study which including hemoglobin > 90 g/L, platelet count >=100*10e9/L, absolute meutrophil count >=1.5*10e9/L;
- •Life expectancy of at least 3 months;
- •Provision of signed and dated written inform consent prior to any study-related procedures, sampling and analyses.
排除标准
- •Active known second malignancy except adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, breast cancer;
- •Patients with primary CNS malignancies;
- •Evidence of severe or uncontrolled systemic diseases, including: active infection, hypertension, chronically unhealed wound or ulcers;
- •Active autoimmnue disease requiring systemic treatment in the last 2 years, or immunodefiency which is on immunosuppressive therapy, chronic systemic or enteric steroid therapy;
- •History of pneumonitis, interstitial lung disease which require steroids or has current pneumonitis/ interstitial lung disease;
- •Any unresolved toxicities from prior therapy greater than CTCAE 5.0 grade 1.
研究组 & 干预措施
KGX101 monotherapy-Dose level 2
干预措施: KGX101 injection (Drug)
KGX101 combo with Envafolimab-Dose level 1
干预措施: KGX101 injection (Drug)
KGX101 combo with Envafolimab-Dose level 1
干预措施: Envafolimab (Drug)
KGX101 combo with Envafolimab-Dose level 2
干预措施: KGX101 injection (Drug)
KGX101 combo with Envafolimab-Dose level 2
干预措施: Envafolimab (Drug)
KGX101 combo with Envafolimab-Dose level 3
干预措施: KGX101 injection (Drug)
KGX101 monotherapy-Dose level 1
干预措施: KGX101 injection (Drug)
KGX101 monotherapy-Dose level 3
干预措施: KGX101 injection (Drug)
KGX101 monotherapy-Dose level 4
干预措施: KGX101 injection (Drug)
KGX101 monotherapy dose expansion
干预措施: KGX101 injection (Drug)
KGX101 combo with Envafolimab-Dose level 3
干预措施: Envafolimab (Drug)
KGX101 combo with Envafolimab dose expansion
干预措施: KGX101 injection (Drug)
KGX101 combo with Envafolimab dose expansion
干预措施: Envafolimab (Drug)
结局指标
主要结局
Numbers of participants with adverse events
时间窗: From baseline to 30 days after the last dose administration.
AE will be collected to assess participants' safety after KGX101 monotherapy or combo with Envafolimab
Number of participants with dose limiting toxicities/DLT within DLT observation period
时间窗: From Day1 after the first priming dose of KGX101 until 21 days post the first target dose ofKGX101
DLT will be observed from start of the first priming dose of KGX101 until 21 days post the first target dose of KGX101
Number of participants with changes of clinical lab abnormalities
时间窗: From screening until 90 days post the last dose administration
Any changes in values of the clinical chemistry, hematology, coagulation and urinalysis will be evaluated
The maximum tolerated dose of KGX101 monotherapy and combination therapy with Envafolimab
时间窗: From Day 1 post the first dosing until 21 days post the the first target dosing
次要结局
- PK parameters: Maximum Concentration (Cmax) of total IL-12(Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.)
- PK Parameters: Time of maximum observed concentration (Tmax)of total IL-12(Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.)
- PK Parameters: Area under the curve (AUC)(Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.)
- PK Parameters- Trough concentration (Ctrough)(Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.)
- Number of participants with changes in the Overall Response (ORR)(From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post the last treatment.)
- PK Parameters: Half- life (T1 /2)(Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.)
- PK Parameters- Systemic clearance (CL)(Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.)
- PK Parameters- Volume of distribution (Vd)(Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.)
- Immunogenicity- Anti-drug antibody (ADA)(Part A: From pre-dose of the first dose of KGX101 treatment until 90 days afrer the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until 90 days after the last dose.)
- Progression free survival (PFS) per RECIST 1.1(From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment.)
- Overall survival(From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment.)