A phase I-II clinical trial to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of EN002-gel in patients with non-melanoma skin cancer and precancerous lesions

EnKang Pharmaceuticals (Australia) Pty Ltd.0 sites95 target enrollmentNovember 27, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 27, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

EnKang Pharmaceuticals (Australia) Pty Ltd.

•All enrolled subjects should meet the following criteria:
•(1\)Able to sign the informed consent form freely and voluntarily, finish the follow\-ups and complete the study assignments;
•(2\)Aged greater than or equal to 18 years old;
•(3\)Study subjects should be (one or more of the following):
•diagnosed with AK by histopathological examination or non\-invasive diagnosis (dermoscopy, skin CT, etc.);
•diagnosed with Bowen's disease by histopathological examination;
•diagnosed with primary basal cell carcinoma of the skin (including nodular, superficial, micronodular and other histopathological types with low risk of recurrence) by histopathological examination;
•diagnosed with primary squamous cell carcinoma of the skin by histopathological examination;
•(4\) The total lesion area of the whole body is not more than 25 cm²;
•(5\)Not suitable for surgical or radiotherapy treatment at the affected area, or unwilling to accept surgical or radiotherapy treatment;

•Subjects have any of the following conditions should not be enrolled:
•(1\)Subjects with known serious hypersensitivity or serious adverse reactions to the investigational drug, or with an allergic constitution;
•(2\)Life expectancy is estimated to be less than 12 weeks;
•(3\)Subjects who have used other topical treatments (e.g., fluorouracil ointment, Imiquimod cream, photodynamic therapy) within 7 d prior to the first dose;
•(4\)Subjects who have received targeted therapy, chemotherapy, immunotherapy and other systemic anticancer therapy within 4 weeks prior to enrollment;
•(5\)Subjects with ulcerate/damaged skin within 5 cm of the target lesion;
•(6\)Subjects with lymph node metastasis or important organ metastasis of tumors by imaging examination;
•(7\)Subjects with neurological/psychiatric, respiratory, cardiovascular, digestive, hematological and lymphatic, endocrine, skeletal\-muscular, or any other disorders or physiological conditions that may impair the results of the study;
•(8\)Subjects with positive antibodies to human immunodeficiency virus (HIV); positive hepatitis B surface antigen (HBsAg) and HBV\-DNA greater than or equal to the lower limit of quantification; positive antibodies to hepatitis C virus (HCV) and HCV\-RNA greater than or equal to the lower limit of quantitation; or positive treponema pallidum antibodies;
•(9\)Pregnant or lactating women, or subjects with a planned pregnancy within 3 months;