The Purpose of This Study is to Evaluate the Safety and Efficacy of D-MNA in Adult Patients With Nodular Basal Cell Carcinoma

SkinJect

Status and phase: Enrolling; Phase 2

Conditions: Nodular Basal Cell Carcinoma

Treatments: Drug: D-MNA 200 mcg; Drug: D-MNA 100 mcg; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06608238

SKNJCT-003

Details and patient eligibility

About

The goal of the study is to learn about the safety and how effective two different strengths of D-MNA compared to a placebo (a look-alike substance that contains no drug) in the treatment of nodular basal cell skin cancer

Full description

A double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of D-MNA which is administered as an intradermal injection in subjects with nodular Basal Cell Carcinoma (nBCC).

About 60 subjects will be enrolled. Enrolled subjects will be randomly allocated to receive D-MNA or placebo injection on the identified target lesion once weekly for 3 weeks.

After two weeks, the target lesion will be excised.

An Interim Analysis will be done after 26-30 subjects would have completed Visit 5/ Excision Visit.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or non-pregnant female ≥ 18 years of age.
2. Clinical diagnosis of a primary, previously untreated, histologically confirmed nodular Basal Cell Carcinoma (nBCC) lesion suitable for excision (at end of the study) with a minimum diameter of 0.5 cm and with a maximum longest diameter of 1.3 cm at the time of biopsy and Visit 2/Baseline.
3. Willing to refrain from exposure to excessive direct sunlight or ultraviolet light and to avoid the use of tanning beds for the duration of the study.
4. Willing and able to receive the test article treatments, comply with study instructions, and commit to all follow-up visits for the duration of the study.

Exclusion criteria

1. Pregnant, lactating, or planning to become pregnant.

2. nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation.

3. History of treated nBCC lesion recurrence or basal cell nevus syndrome.

4. Immunocompromised, based on medical condition (e.g., human immunodeficiency virus), medication use, or other factors.

5. Active malignancy, excluding non-metastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix.

6. Used systemic chemotherapeutic agents within the 12 months prior to Visit 2/Baseline.

7. Clinical laboratory results at Visit 1/Screening within the following ranges: (a) granulocytes < 2,000/mm3, (b) platelets <50,000/mm3, (c) serum creatinine greater than 2 times the upper limit of normal (ULN), (d) aspartate aminotransferase, alkaline aminotransferase, lactate dehydrogenase, or alkaline phosphatase greater than 3 times the ULN.

8. History of sensitivity to any of the ingredients in the test articles .

9. Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.

10. Used the following topical agents within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy: aminolevulinic acid, 5-fluorouracil, diclofenac, ingenol mebutate, tirbanibulin, or imiquimod.

11. Has been treated with liquid nitrogen, surgical excision or curettage within 2 cm of the Target Lesion within 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.

12. Currently enrolled in an investigational drug, biologic, or device study. 12. Used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to enrollment into the study.

13. Unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Arm A

Active Comparator group

Description:

D-MNA 200 mcg, intradermal patch, given once weekly for 2 weeks.

Treatment:

Drug: D-MNA 200 mcg

Arm B

Active Comparator group

Description:

D-MNA 100 mcg intradermal patch, given once weekly for 2 weeks

Treatment:

Drug: D-MNA 100 mcg

Arm C

Placebo Comparator group

Description:

P-MNA, intradermal patch, given once weekly for 2 weeks

Treatment:

Other: Placebo