A Phase 1/2a, First-In-Human, Single and Multiple Ascending Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Intralesional FLD-103 in Subjects with Basal Cell Carcinoma (BCC)

Feldan Therapeutics0 个研究点目标入组 18 人开始时间: 2024年9月20日最近更新: 2024年9月30日

适应症

试验速览

阶段: 1 期
状态: 尚未招募
发起方
入组人数: 18

研究概览研究设计入排标准研究者记录与标识符相似试验

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 85 Years（—）
性别: All

入选标准

•At least 18 years of age and up to 85 years of age, inclusive, at the time of signing the informed consent.
•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.
•At Screening, the subject must have at least a single histologically confirmed nBCC suitable for treatment and final excision by the Investigator.
•A nBCC previously biopsied outside the study as part of standard clinical practice may be re-biopsied within the study, provided that less than 25 percent of the area of the nodular lesion is removed as a result of the second biopsy.
•Target nBCC must be appropriate for a full thickness 2 mm punch biopsy (for lesions from 5 mm up to less than 10 mm diameter) or 3 mm punch biopsy (for lesions from 10 mm to less than 20 mm diameter), taken approximately halfway from the centre or outer border of each target nBCC, within 28 to 42 days prior to Day 1 for histological confirmation at Screening. The biopsy(ies) must remove less than 25 percent of the area of the nBCC.
•Target BCC must, in the assessment of the Investigator, be appropriate for FLD-103 intralesional treatment over the anticipated duration of the study.
•Female volunteers, must:a. Be of non-child-bearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the Screening visit, orb. Be postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and follicle-stimulating hormone (FSH) level and estradiol level consistent with postmenopausal status, per local laboratory guidelines).
•Male volunteers, must:a. Agree not to donate sperm from signing the consent form until at least 90 days after the last dose of study drug.b. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from signing the consent form until at least 90 days after the last dose of study drug.c. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until at least 90 days after the last dose of study drug.

排除标准

•Women of childbearing potential.
•History of sensitivity to any of the components in the Investigational Product (IP) formulation.
•Target lesion in high-risk anatomic location (e.g. ocular/peri-ocular, nose/perinasal, ears, lips/perioral, scalp, fingers/hands).
•Target lesion requiring immediate surgical removal.
•Histologically confirmed concurrent diagnosis of locally advanced or metastatic BCC.
•Use of known inhibitors of the HH signaling pathway (including but not limited to vismodegib, sonidegib, itraconazole) within six (6) months of Screening.
•Use of topical or intralesional treatment within 5 cm of the target BCC (e.g. 5-FU, topical corticosteroids, retinoids) within the specified period
•Use of topical imiquimod, anywhere on the body, within six (6) months of Screening.
•Use of any other systemic therapy, within the specified period.
•Any prior exposure to TG1041, TG1042 (ASN-002), any other adenoviral-based experimental agent, or any form of gene therapy within six (6) months of Screening.
•Has received or is expected to receive phototherapy, including treatment with psoralen plus UVA or UVB therapy, within six (6) months of the Screening visit or during the study.
•Use of another Investigational Product (IP) within three (3) months or five (5) halflives or twice the duration of biological effect (whichever is the longest) preceding the first dose of FLD-103.
•Previous superficial radiation therapy for acne or other cutaneous disorder.
•A history of, or current hepatic disease, or known hepatic or biliary abnormalities that in the opinion of the Investigator would preclude the subject from participation in the study.
•Moderate to severe renal impairment, including subjects on chronic renal dialysis and subjects with a history of nephrectomy or kidney transplant (regardless of renal function)
•History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses.
•Alcohol or drug abuse within the past 180 days, a positive pre-study drug screen or other current mental health condition (including, but notlimited to, psychiatric disorder or dementia), which may affect study compliance or prevent understanding of the aims, investigational procedures, or possible consequences of the study.
•History or current evidence of any condition, laboratory abnormality or situation which, in the Investigator’s opinion, may put the subject’s safety at significant risk, confound the study results, interfere with the evaluation of the target lesion/treatment area or interfere with the subject’s participation in the study, (for example, but not limited to, other clinically active or uncontrolled skin disorders or tattoos that would interfere with evaluation of the area surrounding the target BCC, uncontrolled systemic disease such as metabolic dysfunction, organ transplant patients, immunocompromised patients, and any other physical examination findings, or abnormal clinical laboratory findings).
•Diagnosis of Xeroderma Pigmentosum or any other skin disorder that is associated with an abnormal rate of development of skin cancers or which may interfere with administration of the treatment and/or assessment of the target nBCC.
•History of any malignancy within the past five (5) years or has a known malignancy that is progressing or requires active treatment excluding BCC or squamous cell carcinoma in situ or in situ cervical cancer or other

研究者

发起方

Feldan Therapeutics

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