NCT04592484已完成1 期
A First-in-Human Study of CDK-002 (exoSTING) in Subjects With Advanced/Metastatic, Recurrent, Injectable Solid Tumors, With Emphasis on Squamous Cell Carcinoma of the Head and Neck, Triple Negative Breast Cancer, Anaplastic Thyroid Carcinoma, and Cutaneous Squamous Cell Carcinoma
Codiak BioSciences15 个研究点 分布在 2 个国家目标入组 27 人开始时间: 2020年9月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 15
- 主要终点
- To determine the safety and tolerability of ascending doses of CDK-002
研究概览
简要总结
This is a first-in-human, Phase 1/2 open-label, multicenter, dose escalation, safety, pharmacodynamic, and PK study of CDK-002 in subjects with advanced/metastatic, recurrent, injectable solid tumors, whose disease has progressed despite receiving standard of care treatment. CDK 002 will be administered intratumorally (IT).
Part A will enroll subjects with advanced/metastatic, recurrent, injectable solid tumors with emphasis on head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), anaplastic thyroid carcinoma (ATC) and cutaneous squamous cell carcinoma (cSCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Criteria for Inclusion:
- •Age ≥ 18 years at the time of signing the informed consent form.
- •Histologically confirmed advanced, recurrent or metastatic injectable solid tumor and has received the following prior therapy:
- •HNSCC: Subject must have been previously treated with a platinum-based chemotherapy regimen and/or a programmed cell death-protein 1 (PD-1) inhibitor.
- •TNBC: Subject must have been treated with at least 1 chemotherapy regimen and/or PD-L1 or PD-1 inhibitor for metastatic disease.
- •ATC: Subject must be considered inoperable and not considered to benefit from additional chemotherapy and/or radiation.
- •cSCC: Subject must have previously been treated with radiation therapy and/or chemotherapy and/or PD-L1 or PD-1 inhibitor.
- •Subjects with other advanced solid tumors that have progressed following standard therapy or for which there is no standard of care therapy with an overall survival (OS) benefit.
- •Measurable disease per RECIST v1.1 and ≥1 lesion that is measurable (ie, ≥1.0 cm by CT, MRI, or ruler or caliper measurements for cutaneous lesions or other superficial lesions in longest diameter [non-lymph nodes] or ≥1.5 cm in shortest diameter for lymph nodes) and amenable to tumoral injection and biopsy per Investigator assessment.
- •Agrees to have a pre-treatment tumor biopsy within 7 days prior to the first dose of CDK-002, and 2 on-treatment tumor biopsies of the same lesion. Biopsies may be core needle, incisional, or excisional biopsies. For cutaneous lesions, a punch biopsy may be acceptable. Fine needle aspiration (FNA) is not acceptable.
- •Understands and can comply with the study requirements and has signed the informed consent form.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •Life expectancy of at least 3 months.
- •Acceptable liver function.
- •Acceptable renal function.
- •Acceptable hematologic status.
- •Negative serum pregnancy test (for women of child-bearing potential) within 72 hours before the first dose of CDK-002.
排除标准
- •Criteria for Exclusion:
- •Prior treatment with a STING agonist.
- •Cytotoxic chemotherapy, biologic agents, investigational agents, or radiation therapy within 4 weeks prior to the first dose of CDK 002 (6 weeks for nitrosoureas or mitomycin C). The interval can be reduced to 2 weeks for bone-only radiation therapy.
- •Small-molecule kinase inhibitors or hormonal anticancer agents within 14 days prior to the first dose of CDK
- •Clinically significant ongoing AEs that have not returned to baseline or to Grade 1 NCI CTCAE v5.
- •Immunosuppressive agents including corticosteroids within 14 days of first dose of CDK
- •Topical, intranasal or inhaled corticosteroids, physiologic doses of systemic steroids or limited treatment with systemic steroids (ie, for IV contrast prophylaxis) may be administered with Sponsor approval.
- •Major surgery within 6 weeks or minor surgery (excluding tumor biopsies) within 14 days prior to the first dose of CDK 002 or if subject has not clinically recovered.
- •Clinically active central nervous system (CNS) metastases or carcinomatous meningitis. Subjects with stable brain metastasis may be enrolled with Sponsor approval.
- •Metastatic liver involvement that exceeds one-third of total liver volume.
- •Clinically significant cardiovascular disease including but not limited to New York Heart Association Class III or IV heart failure, myocardial infarction or stroke within the past 6 months prior to the first dose of CDK 002, uncontrolled arrhythmia, or severe aortic stenosis. Sponsor approval of subjects with an arrhythmia is required.
- •History of myocarditis.
- •Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. Prophylactic antibiotics are acceptable.
- •Prior organ or stem cell transplant.
- •Primary immune deficiency.
- •Pregnant or nursing women.
- •Active Hepatitis B or C infection.
结局指标
主要结局
To determine the safety and tolerability of ascending doses of CDK-002
时间窗: up to 2 years
Incidence of treatment-emergent adverse events as assessed by CTCAE
次要结局
未报告次要终点
研究者
研究点 (15)
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