NCT07100925撤回1 期
An Open-Label Study of Tolododekin Alfa (ANK-101) in Renal Allograft Recipients With Resectable, High-Risk Cutaneous Squamous Cell Carcinoma
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 20
- 主要终点
- Major Pathological Response (MPR) rate
研究概览
简要总结
A study of tolododekin alfa (also known as ANK-101) administered prior to surgery in kidney transplant participants that also have high-risk 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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have histologically or cytologically confirmed high-risk and/or locoregionally metastatic CSCC
- •Have measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- •Are renal allograft recipients on a stable immunosuppressive regimen.
- •Have adequate renal function defined as creatinine clearance ≥ 30 mL/min as determined by the Cockcroft-Gault equation.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Have a life expectancy > 12 months.
- •Have baseline electrocardiogram (EKG) without evidence of acute ischemia or prolonged QT interval
- •Heterosexually active women of childbearing potential (WOCBP) must agree to use at least 2 forms of highly effective methods of contraception
- •All male participants who are not sterile must commit to the use of a reliable method of birth control or abstinence.
- •Last dose of previous anticancer therapy (including investigational agents) ≥ 28 days or surgical intervention ≥ 21 days prior to the first dose of study drug.
- •Resolution of all prior anticancer therapy toxicities (except for alopecia or vitiligo) to ≤ Grade 1
- •Willingness to provide fresh tumor biopsy specimens
- •Capable of understanding and complying with protocol requirements.
- •Provides written informed consent for the study.
排除标准
- •Have AJCC Stage IV disease, known distant metastasis, or findings on imaging that are considered to be highly suspicious for distant metastasis.
- •Have injectable tumors impinging upon major airways or blood vessels.
- •Have had prior treatment with recombinant interleukin-12 (IL-12).
- •Have had prior radiation therapy within 28 days for CSCC at the site of injection.
- •Have received live vaccines within 28 days prior to the start of study drug (C1D1).
- •Have any history of transplant-related deoxyribonucleic acid (DNA) viral infections, such as human polyomavirus 1 (BKV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) within 3 months of C1D
- •Have primary or acquired immunodeficient states (e.g., leukemia, lymphoma) requiring active therapy.
- •A WOCBP who has a positive serum pregnancy test prior to C1D1 or female participant who is breastfeeding
- •Have known active uncontrolled hepatitis B, hepatitis C (HCV), or human immunodeficiency virus (HIV) infection.
- •Have active autoimmune disease or medical conditions requiring chronic steroid (i.e., ≥ 20 mg/day prednisone or equivalent) or other immunosuppressive therapy beyond that required for maintenance allograft rejection prevention.
- •Have congestive heart failure, active coronary artery disease, unevaluated new onset angina, unstable angina, or clinically significant cardiac arrhythmias.
- •Have uncontrolled bleeding disorders.
- •Have a history of allergic reactions attributed to compounds of similar biological composition to IL-12, aluminum hydroxide, or drugs formulated with polysorbate-
- •Have other systemic conditions or organ abnormalities that may interfere with the conduct the current study.
- •Have any acute or chronic psychiatric problems or substance abuse disorder that make the participant unsuitable for participation.
研究组 & 干预措施
tolododekin alfa (ANK-101) IT Injection
Experimental
Participants will receive 2 cycles of tolododekin alfa before surgical resection of CSCC tumor
干预措施: tolododekin alfa (Drug)
结局指标
主要结局
Major Pathological Response (MPR) rate
时间窗: 3 months
The percentage of participants who have ≤ 10% viable cancer cells in the surgical pathology sample among all response evaluable participants.
次要结局
- Event Free Survival (EFS)(Up to 3 years)
- Relapse Free Survival (RFS)(Up to 3 years)
- Pathological Complete Response (pCR)(3 months)
- Best Overall Response Rate (BORR)(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
研究者
相似试验
招募中
1 期
A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung CancerNCT07027514Ankyra Therapeutics, Inc60
招募中
1 期
Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney TransplantNCT05027906Eledon Pharmaceuticals48
已完成
2 期
Tocilizumab for Renal Graft InflammationLate Complication From Kidney TransplantNCT02108600Flavio Vincenti33
已完成
2 期
Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)Leukemia, Lymphocytic, ChronicNCT00055146Eisai Inc.41
Unknown
3 期
TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.Liver Function FailureNCT03216668Nhat Nhat Pharmaceutical Company140