NCT06422936进行中（未招募）2 期
SPOTLIGHT 204: A Multicenter, Phase 2b, Open-label, Non-randomized, Clinical Trial to Evaluate Safety, Tolerability and Preliminary Efficacy of Intra-lesional BO-112 in Patients With Resectable Primary Low and High Risk Basal Cell Carcinoma
Highlight Therapeutics15 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2024年5月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 15
- 主要终点
- Number of Participants with Visual and Pathological Response
研究概览
简要总结
This is a multicenter, phase 2b, open-label, non-randomized, clinical trial to evaluate safety, tolerability, pharmacodynamics and preliminary efficacy of intra-lesional BO-112 in patients with resectable primary low and high risk basal cell carcinoma.
- primary endpoint is composite visual and pathological response [at surgery] on patient level as assessed by central review
- secondary endpoints are
- Occurrence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death on patient level.
- Pathological response [at surgery] on patient level assessed by the investigator and central review, respectively, and visual response [during the study and at surgery] on patient level assessed by the investigator and central review, respectively.
详细描述
This study will be conducted in patients with resectable primary low- and high-risk basal cell carcinoma according to the following definition:
Low-risk nodular BCC and/or low-risk superficial BCC:
• Participants with primary resectable nodular and/or superficial BCC with well-defined borders with:
- At least one lesion with the longest diameter from 5 to 10 mm located on cheeks, forehead, scalp, neck, and pretibial. OR
- At least one lesion with the longest diameter from 5 to 20 mm located on trunk and extremities (excluding hands, feet, nail units, pretibial, and ankles).
High-risk BCC:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 18 years old [or the legal age of consent in the jurisdiction in which the study is taking place], at the time of signing the informed consent.
- •Type of Participant and Disease Condition
- •Has primary resectable low or high risk basal cell carcinoma according to the protocol definition
- •Has diagnostic punch biopsy of all lesions intended for injection available prior to the first dose of BO-
- •Has adequate laboratory values as defined per protocol
- •Sex and Contraceptive/Barrier Requirements
- •Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug.
- •Women of childbearing potential must be willing to use two effective methods of birth control while treated with BO-112 and for 4 weeks after the last treatment. The two forms of birth control authorized are defined as the use of a barrier method of contraception (condom with spermicide) in association with one of the following methods of birth control: bilateral tubal ligation; combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives from the time of informed consent.
- •Male patients with female partners of childbearing potential must be willing to use two adequate contraception methods while treated with BO-112 and for 4 weeks after treatment completion.
- •Informed Consent
- •Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Able and willing to comply with all study requirements, including surgical removal of lesion/lesion site at completion of study.
排除标准
- •Has history of hypersensitivity to BO-112 or its excipients/vehicle.
- •Has any BCC lesion(s) planned for injection in site of prior radiation within 6 months prior to first dose of BO-
- •Has any BCC lesion(s) planned for injection within 2 cm of the open eyelid margins
- •Has Gorlin's syndrome
- •Has clinically active or uncontrolled skin disease or tattoos that would interfere with evaluation of the area surrounding the target lesion
- •Has another malignant disease requiring treatment
- •Has a history of immunological disorder, severe allergic reaction, moderate or severe asthma or known history of anaphylaxis or any other serious adverse reactions to the investigational products.
- •Female participants: lactating or pregnant.
- •Has received a live vaccine or messenger ribonucleic acid (mRNA) Corona virus disease (COVID) vaccine within 7 days prior to the first dose of study drug or has a vaccination planned during treatment with BO-112 and within 7 days after the last study drug administration.
- •Is immunocompromised. Systemic corticosteroids at >10 mg/day prednisone or equivalent within 1 week prior to the first dose of BO-
- •Has any prior systemic anti-lesion therapy or local treatment for study lesions prior to first dose; any chemotherapy or immunotherapy for any other malignancy within 24 months prior to the first dose of BO-
- •Has any experimental or investigational agents within one month of first BO-112 injection.
- •Has received or is expected to receive treatment with psoralen plus ultraviolet A (UVA) or ultraviolet B (UVB) therapy within 6 months prior to the first dose of BO-
- •Requires / or has used topical products within 5 cm of a treatment-targeted BCC lesion or systemic therapies that might interfere with the evaluation of the study medication during the study.
- •Has any other concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational [used for a not approved indication and in the context of a research investigation]) within 28 days of first study drug administration; or plans to participate in an experimental drug study while enrolled in this study.
- •Has any medical contraindications to surgery
研究组 & 干预措施
Cohort I
Experimental
patients with low risk nodular and/or low risk superficial BCC
干预措施: BO-112 (Drug)
Cohort II
Experimental
patients with high risk BCC
干预措施: BO-112 (Drug)
结局指标
主要结局
Number of Participants with Visual and Pathological Response
时间窗: at surgery
The composite primary endpoint of the visual and pathological response is defined as visual and pathological response on patient level.
Number of Participants with Visual and Pathological Response
时间窗: at 24 weeks
Visual and pathological response of all treated BCC lesions on participant level assessed by central review
次要结局
- Number of Participants with Treatment-Related Adverse Events assessed by CTCAE 5.0(through study completion, average 7 months)
- Extent of Pathological Response(at 24 weeks)
- Change of Visual Lesion Appearance(at baseline and at 24 weeks)
- Number of Participants with BCC Recurrence(at 12 and 24 months after surgery)
- Extent of Pathological Response(at surgery)
- Change of Visual Lesion Appearance(at baseline and at surgery)
研究者
研究点 (15)
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