[Translation] Phase I-II clinical trial of EN002 topical gel to evaluate its tolerability, safety, pharmacokinetics and preliminary efficacy in patients with non-melanoma skin cancer and precancerous lesions
第一阶段
主要目的:
1) 评价EN002外用凝胶治疗非黑色素瘤皮肤癌的安全性和耐受性;
次要目的:
1)评价EN002外用凝胶在非黑色素瘤皮肤癌受试者中的药代动力学特征;
2)探索EN002外用凝胶治疗非黑色素瘤皮肤癌的疗效,为后续阶段试验给药剂量和给药方案提供依据;
第二阶段
主要目的:
1) 评价EN002外用凝胶治疗非黑色素瘤皮肤癌的抗肿瘤疗效,并确定适应症;
次要目的:
1) 评价EN002外用凝胶治疗非黑色素瘤皮肤癌的有效性和安全性;
2) 评价受试者的生活质量改善情况。
[Translation] Phase I
Main objectives:
1) To evaluate the safety and tolerability of EN002 topical gel in the treatment of non-melanoma skin cancer;
Secondary objectives:
1) To evaluate the pharmacokinetic characteristics of EN002 topical gel in subjects with non-melanoma skin cancer;
2) To explore the efficacy of EN002 topical gel in the treatment of non-melanoma skin cancer and provide a basis for the subsequent phase of trial dosing and administration regimen;
Phase II
Main objectives:
1) To evaluate the anti-tumor efficacy of EN002 topical gel in the treatment of non-melanoma skin cancer and determine the indications;
Secondary objectives:
1) To evaluate the efficacy and safety of EN002 topical gel in the treatment of non-melanoma skin cancer;
2) To evaluate the improvement of the quality of life of the subjects.