评价AFN0328 注射液治疗HPV16 和/或HPV18 相关宫颈高级别鳞状上皮内病变[HSIL]的安全性、耐受性、PK、PD、免疫原性和初步疗效的I 期临床试验
[Translation] A Phase I clinical trial to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of AFN0328 injection in the treatment of HPV16 and/or HPV18-related high-grade cervical squamous intraepithelial lesions [HSIL]
主要目的:
PART1:剂量递增阶段
评价本品在HPV16和/或HPV18相关宫颈高级别鳞状上皮内病变[HSIL]患者中的安全性和耐受性,探索最大耐受剂量(MTD)。
PART2:病例拓展阶段
评价本品在HPV16和/或HPV18相关宫颈高级别鳞状上皮内病变[HSIL]患者中的安全性、耐受性和初步疗效,确定II期临床试验推荐剂量(RP2D)。
次要目的:
评价本品在HPV16和/或HPV18相关宫颈高级别鳞状上皮内病变[HSIL]患者中的药代动力学(PK)特征。
评价本品在HPV16和/或HPV18相关宫颈高级别鳞状上皮内病变[HSIL]患者中的免疫原性。
评价本品在HPV16和/或HPV18相关宫颈高级别鳞状上皮内病变[HSIL]患者中的药效动力学(PD)特征:细胞免疫反应水平及引起的CD4+和CD8+T淋巴细胞反应。
探索性目的:
评价本品在HPV16和/或HPV18相关宫颈高级别鳞状上皮内病变[HSIL]患者中的药效动力学(PD)特征:血清细胞因子(IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-6、IL-10和IL-17A)的变化。
[Translation] Main purpose:
PART1: Dose escalation phase
To evaluate the safety and tolerability of this product in patients with HPV16 and/or HPV18-related high-grade cervical squamous intraepithelial lesions [HSIL], and explore the maximum tolerated dose (MTD).
PART2: Case expansion phase
To evaluate the safety, tolerability and preliminary efficacy of this product in patients with HPV16 and/or HPV18-related high-grade cervical squamous intraepithelial lesions [HSIL], and determine the recommended dose (RP2D) for Phase II clinical trials.
Secondary purpose:
To evaluate the pharmacokinetic (PK) characteristics of this product in patients with HPV16 and/or HPV18-related high-grade cervical squamous intraepithelial lesions [HSIL].
To evaluate the immunogenicity of this product in patients with HPV16 and/or HPV18-related high-grade cervical squamous intraepithelial lesions [HSIL].
To evaluate the pharmacodynamic (PD) characteristics of this product in patients with HPV16 and/or HPV18-related high-grade cervical squamous intraepithelial lesions [HSIL]: the level of cellular immune response and the CD4+ and CD8+ T lymphocyte responses induced.
Exploratory purpose:
To evaluate the pharmacodynamic (PD) characteristics of this product in patients with HPV16 and/or HPV18-related high-grade cervical squamous intraepithelial lesions [HSIL]: changes in serum cytokines (IFN-γ, TNF-α, IL-2, IL-4, IL-5, IL-6, IL-10 and IL-17A).
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