ACTRN12624000310561尚未招募1 期
A Phase 1, Open Label, First in Human (FIH) Study Investigating Photodynamic Therapy (PDT) with INV043 0.5% Ointment in Adults with Non-melanoma Skin Cancers
Invion Limited0 个研究点目标入组 150 人开始时间: 2024年3月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion Criteria
- •1.Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and is willing and able to return for all study visits and comply with all protocol requirements and procedures.
- •2.Participant is at least 18 years of age at the time of signing the informed consent.
- •3.ECOG performance status of 0 or 1.
- •4.Participants must have a life expectancy of greater then 12 months in the opinion of the Investigator.
- •5.Participants must have measurable disease based on RECIST 1.1.
- •6.Participants must have available archival tissue (at least 15 consecutive, unstained, formalin-fixed, paraffin embedded [FFPE] slides or 1 FFPE block) OR, alternatively, a fresh tumour biopsy sample. Participants without any archival tissue or fresh biopsy sample, or who refuse to provide archival tissue may be approved to enrol on a case-by-case basis in discussion with the Sponsor.
- •7.At least one primary, clinically diagnosed and histologically confirmed, Non-melanoma Skin Cancer lesion. Lesion must meet the following guidelines:
- •Target lesion must be between 1.0 to 2.0 cm (inclusive) in longest diameter.
- •Target lesion must be located on a body site easily accessible for topical application by the clinician, excluding the face and scalp area, genitals, perianal area, eyelids, ears.
- •Target lesion must not be located in areas with significant confounding factors, such as tattoos or deformities, that may put participant at a higher risk of treatment-related toxicity and/or interfere with the integrity of study outcome.
- •Participants with lesions that are greater then 2.0 cm and/or lesions located in the face, scalp, genitals, perianal, eyelids or ears, may be allowed on a case-by-case basis in discussion with study Sponsor if deemed unlikely to put participant at a higher risk of treatment-related toxicity and/or interfere with the integrity of study outcome.
- •8.For Part 1 and Part 2 (dose escalation cohorts), all participants must meet either of the following tumour-type criteria:
- •a.Non-metastatic cutaneous SCC.
- •b.Other NMSCs may be approved on a case-by-case basis by Sponsor if deemed to be in the participant’s best interest by PI judgment, and unlikely to put participant at a higher risk of treatment-related toxicity and/or interfere with the integrity of study outcome.
- •10.Participants must not require immediate surgical removal of treatment-targeted lesions. Targeted lesion must, in the assessment of the Investigator, be appropriate for study treatment over the anticipated duration of the study. Lesions that otherwise exhibit aggressive features by Investigator judgment should not be included and should be treated with appropriate standard of care.
- •11.The participant must be willing and able to abstain from using prohibited therapies, including the use of moisturizers or other topical non-medical treatments at the treatment site, for at least 24 hours before INV043 PDT and during study Treatment Period. .
- •12.Agree to abstain from sun exposure at the treatment site for the duration of the study to End of Treatment Visit (EOTV).
- •13.Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (ß-hCG) test within 48 hours before the first dose of treatment administration and must not be breastfeeding.
- •14.WOCBP are defined as those who are not surgically sterile or post-menopausal. Femal
排除标准
- •1. Participants with high-risk cutaneous SCC as per the National Comprehensive Cancer Network (NCCN) guidelines. High risk criteria includes depth of the tumour >2 mm, tumour diameter >2 cm, poor differentiation, perineural invasion, or involvement of the ear or lip mucosa. Additional high-risk factors include immunocompromised participants and
- •fast-growing or recurrent tumours.
- •2. Participants with morpheaform, metatypical, basosquamous, or infiltrating BCC histologies, if the target lesion is a recurrent BCC.
- •3. Participants with known metastatic disease from the disease to be studied, e.g., metastatic cutaneous SCC or BCC.
- •4. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with study sponsor, if deemed unlikely to put participant at a higher risk of treatment-related toxicity and/or interfere with the integrity of study outcome.
- •5. Use of another investigational product within 60 days, within 5 half-lives, or twice the duration of biological effect, whichever is the longest, prior to INV043 PDT.
- •6. Current participation in any other investigational trial.
- •7. Participants have undergone skin punch biopsies on the target lesion within
- •14 days of INV043 PDT.
- •8. Participants with a history of sensitivity to any of the components in the IP
- •formulation.
- •9. Evidence of dermatological disease or histological evidence of a confounding
- •skin condition in the treatment area, including but not limited to superficial BCC, worse level/grade of BCC, rosacea, psoriasis, atopic dermatitis, eczema, or any other tumour in the treatment area.
- •10. Evidence of xeroderma pigmentosa or other genetic dermal conditions.
- •11. Participants with a diagnosis of porphyria.
- •Participants with a history of photodermatosis.
- •13. Use of drugs with phototoxic or photoallergic potential.
- •14. Treatment for any of the target lesions within 60 days of screening visit by
- •any of the following treatments: Liquid nitrogen, Photochemotherapy (psoralene and ultraviolet A radiation, PUVA), long wave ultraviolet radiation (UVB light), surgical excision or curettage within 2 cm of target lesion; Systemic retinoids; Ionizing radiation or intralesional injections or; Undergone a skin resurfacing procedure, i.e., chemical peel, laser resurfacing, dermabrasion within the last 30 days.
- •15. Treatment with the following topical agents within 30 days prior to the screening visit: methyl aminolevulinate, aminolevulinate, 5-fluorouracil, corticosteroids, retinoids, diclofenac, hyaluronic acid, imiquimod.
- •16. History of recurrence of the target lesion. Participants with recurrent target lesion may be allowed on a case-by-case basis in discussion with study Sponsor if deemed unlikely to put participant at a higher risk of treatment- related toxicity and/or interfere with the integrity of study outcome.
- •17. Systemic use of immunosuppressive drugs of > 10mg Prednisolone equivalent within 30 days prior INV043 PDT. Topical, inhaled, or limited duration steroid use, e.g., for contrast allergy prophylaxis, may be allowed on a case-by-case basis in discussion with study Sponsor if deemed unlikely to put participant at a higher risk of treatment-related toxicity and/or interfere with the integrity of study outcome.
- •18. Use of therapeutic anti-coagu
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