[Translation] An open-label, single-arm phase I clinical study evaluating the safety, tolerability, and efficacy of AVL-102 in patients with high-grade intraepithelial lesions associated with untreated HPV16/18/52/58 infection.
一. Ia期剂量递增阶段
1. 主要目的:1)评估对使用AVL-102注射液患者的安全性和耐受性;2)确定推荐扩展剂量(RDE)及II期临床试验推荐剂量(RP2D)。
2. 次要目的:1)评估不同剂量水平诱导的抗原特异性抗体和细胞介导的免疫应答反应;2)初步评价不同剂量水平治疗HPV16/18/52/58感染相关高级别上皮内病变患者的有效性。
3. 探索性目的:1)探索PK特征;2)探索给药后外周血中相关细胞因子的水平。
二. Ib期剂量扩展阶段
1. 主要目的:评估对使用AVL-102注射液患者的有效性。
2. 次要目的:1)评估安全性和耐受性;2)评估RP2D剂量水平的相应给药方案是否可以诱导抗HPV16/18/52/58抗原特异性抗体和细胞介导的免疫应答反应。
3. 探索性目的:探索给药前后外周血中相关细胞因子的水平。
[Translation] I. Phase Ia Dose Escalation Phase
1. Primary Objectives: 1) To evaluate the safety and tolerability of AVL-102 injection in patients; 2) To determine the recommended extended dose (RDE) and the recommended dose for Phase II clinical trials (RP2D).
2. Secondary Objectives: 1) To evaluate the antigen-specific antibody and cell-mediated immune responses induced by different dose levels; 2) To preliminarily evaluate the efficacy of different dose levels in treating patients with HPV16/18/52/58 infection-related high-grade intraepithelial lesions.
3. Exploratory Objectives: 1) To explore PK characteristics; 2) To explore the levels of relevant cytokines in peripheral blood after administration.
II. Phase Ib Dose Expansion Phase
1. Primary Objective: To evaluate the efficacy of AVL-102 injection in patients.
2. Secondary Objectives: 1) To evaluate safety and tolerability; 2) To evaluate whether the corresponding dosing regimen at the RP2D dose level can induce antigen-specific antibodies against HPV16/18/52/58 and cell-mediated immune responses.
3. Exploratory purpose: To explore the levels of relevant cytokines in peripheral blood before and after drug administration.