None listed
Conditions
Brief summary
The purpose of this study is to assess the acceptability, safety, how your body interacts and the effectiveness of the EN002-gel in patients with non-melanoma skin cancer and precancerous lesions, including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), Actinic keratosis (AK), and Bowen's disease (BD). Who is it for? You may be eligible for this trial if you are aged between 18 years or older, have been diagnosed with basal cell carcinoma (BCC), squamous cell carcinoma (SCC), Actinic keratosis (AK), or Bowen's disease (BD). Study details This study comprises two phases. Currently, Phase I clinical trials are underway in China and Australia. In Phase 1, participants will be grouped into small cohorts, with each group receiving topical administration of EN002-gel on affected skin once every 2 days for a duration of 3 weeks. We will test five different dose levels (0.008, 0.016, 0.027, 0.04, and 0.06 mg EN002 per cm^2) to assess the safety, tolerability, and EN002 gel concentration in the blood of patients with non-melanotic skin cancer. How many people will participate in this clinical trial? We anticipate enrolling approximately 25 participants from both Australia and China for the Phase I study. In Australia, two sites will participate, with a planned total of 8 participants. Australian subjects will be allocated to receive either 0.04 mg/cm^2 or 0.06 mg/cm^2 of EN002 based on when they participate in the study. The Phase II study comprises four cohorts, each representing different tumor or precancerous lesion types, including 35 cases of AK, 12 cases of SCC, 12 cases of BCC, and 11 cases of BD. This sums up to a total of 70 required participants for the Phase II study in China and Australia. The purpose and prospects of this clinical trial It is hoped that this clinical trial can help to evaluate the safety, tolerance and efficacy of EN002 gel in the treatment of non-melanoma skin cancer and other diseases, and provide a basis for the dosage and administration scheme of the subsequent phase of the trial.
Interventions
This study is a non-randomized, single arm, global multicenter clinical trial, with all participants assigned to the treatment group. No control group is included in this study.
Investigational drug code: EN002
Active Ingredient: DNA replication initiation proteins (DRIPs) inhibitors
Dosage form: Topical gel
Specification: 40 mg:10 g and 20 mg:10 g
Route of administration: Topical application
Method of administration: Spread the EN002 gel evenly on the lesion, avoiding flushing and rubbing, co
This study is a non-randomized, single arm, global multicenter clinical trial, with all participants assigned to the treatment group. No control group is included in this study. Investigational drug code: EN002 Active Ingredient: DNA replication initiation proteins (DRIPs) inhibitors Dosage form: Topical gel Specification: 40 mg:10 g and 20 mg:10 g Route of administration: Topical application Method of administration: Spread the EN002 gel evenly on the lesion, avoiding flushing and rubbing, cover with gauze and fix with non-irritating adhesive tape. Ensure that the drug is in contact with the skin for 4±0.5 h per dose. Clean and wipe the administration site with normal saline at room temperature to remove the drug. The administration of the IP will be carried out either by the investigators or by designated site personnel. Treatment cycle and dosing frequency: Phase I: The phase I trial is a single dose incremental trial with a total of 5 dose groups. Based on non-clinical study data, the initial dose was set at 0.008 mg EN002/cm^2, while the remaining dose groups were 0.016, 0.027, 0.04, and 0.06 mg EN002/cm^2. During the single administration phase, observe for 2 days after the first administration; During the multiple administration stage, the drug should be administered once every other day for 21 consecutive days; Lasting for a total of 24 days. Participants will undergo all treatments at the study sites. The amount of gel for each dosage will be measured using positive-displacement pipettes. Phase II: The dose administered: The maximum tolerated dose (MTD) is determined by isotonic regression at the end of Phase I study. Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) is achieved in the Phase I study, comprehensive evaluation will be performed to finally select the appropriate dose for the Phase II study. The duration of administration: once every other day for 21 days. Actual dosing frequency and treatment cycle can be modified based on the tolerability, safety, Pharmacokinetics (PK) parameters and efficacy data of the study drug from the Phase I study. The mode of administration: Topical administration. Separate cohorts will be enrolled for Phase I and Phase II. However, the same participants can be enrolled to both Phase I and Phase II if they meet the study inclusion and exclusion criteria during the screening periods for each phase.
Sponsors
EnKang Pharmaceuticals (Australia) Pty Ltd.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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; (6) Major organs’ functions meet the following criteria: ·Hematology: neutrophil greater than or equal to 1.5×109 /L, platelets greater than or equal to 50×109 /L, hemoglobin greater than or equal to 9.0 g/dL; ·Liver function: total bilirubin less than or equal to 1.5 x ULN, except for those with Gilbert syndrome; ALT/AST less than or equal to 2.5 x ULN in the absence of liver metastases; ·Coagulation: international normalized ratio (INR) less than or equal to 1.5 x ULN and activated partial thromboplastin time (APTT) less than or equal to 1.5 x ULN (INR and APTT are within the safe and effective therapeutic range as judged by the investigator for those on anticoagulation); ·Renal function: serum creatinine less than or equal to 1.5 x ULN, or creatinine clearance greater than or equal to 60 mL/min/1.73 m2 (for those with creatinine > ULN); urine protein less than or equal to 1+ (if greater than or equal to 2+, 24 h urine protein test is required; if 24 h urine protein < 1 g, enrollment is allowed); ·Cardiac function: Left ventricular ejection fraction (LVEF) > 50% by echocardiography (ECHO) or multi-gated acquisition (MUGA); (7) Men and women of childbearing potential must agree to take effective contraception measures from the time they sign the informed consent form until 3 months after the last dose of the investigational drug; women of childbearing potential must have a negative clinical pregnancy test result within 7 d prior to the first dose of the investigational drug; and postmenopausal women must be amenorrheic for at least 12 months before they are considered infertile.
Exclusion criteria
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; (10) Subjects who have participated in any other clinical trial within 3 months prior to this study; (11) Other conditions judged by the investigator to be ineligible for the study.
Outcome results
None listed