An Open-Label Phase 1/2a Clinical Trial to Evaluate the Safety, Immunogenicity, and Preliminary Efficacy of a Lentiviral Vector-Based Therapeutic Vaccine Against Human Papilloma Virus (Lenti-HPV-07) in Participants With HPV-Associated Oropharyngeal Squamous Cell Cancer or Cervical Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV).
The main questions aim to answer are:
- Is Lenti-HPV-07 safe?
- Does Lenti-HPV-07 induce an immune response?
Participants will be assigned to a group based on their cancer type
- either study drug group A: recurrent and/or metastatic cancer
- or study drug group B: newly diagnosed with locally advanced cancer
After they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year.
详细描述
As of 06Nov2025 the recruitment in ARm A of the study (recurrent/metastatic cancers) has been closed to further enrollment, in accordance with the protocol and the study's prespecified operational and/or scientific considerations. No new participants will be enrolled into Arm A, and no additional study drug will be administered within this arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •histologically confirmed invasive HPV-related oropharyngeal or cervical cancer
- •ECOG performance status of 0 or 1
- •adequate hepatic, renal, pulmonary, and bone marrow/hematological function
排除标准
- •- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection
研究组 & 干预措施
Arm A : Refractory newly diagnosed
Refractory recurrent and/or metastatic cervical or oropharyngeal cancer that is not amenable to local therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy).
干预措施: Two IM injections Lenti-HPV-07 (Drug)
Arm B : newly diagnosed locally advanced
Participants who have newly diagnosed locally advanced HPV-related oropharyngeal cancer (defined by AJCC 8th edition [ie, T1-2N2-N3, T3-T4N0-N3]) or cervical cancer (stages IB to IVA) that has never been treated with curative intent, and who are candidates to begin an SoC treatment (surgery, radiation therapy with or without chemotherapy).
干预措施: One IM injection Lenti-HPV-07 (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 12 months after last injection
Frequency, intensity, and relationship of adverse events with vaccine administration per CTCAE v5.0
OBD
时间窗: 28 days after last injection
To identify the optimal biological dose (OBD) and schedule for subsequent trials of Lenti-HPV-07
次要结局
- Immunogenicity(12 months after last injection)
- PD-L1 expression(12 months after last injection)