NCT05357898终止1 期
A Phase 1/2, First-in-Human, Multicenter, Open-Label Study of SQZ-eAPC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitor(s) in Patients With HPV16+ Recurrent, Locally Advanced, or Metastatic Solid Tumors
SQZ Biotechnologies18 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 18
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0
研究概览
简要总结
This is a Phase 1/2, first-in-human, open label, multicenter study to assess safety and tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV as monotherapy and in combination with pembrolizumab in patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors. The study includes patients with head and neck, cervical, anal, vulvar, or penile cancer.
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
- •All Patients:
- •Male or female patients ≥18 years of age
- •Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
- •At least 1 measurable lesion according to RECIST 1.1
- •Must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Screening and on Cycle 2 Day 8 (+/- 2 days)
- •Patients must agree to venous access for leukapheresis and be willing to have a central line inserted if venous access is an issue
- •Adequate organ function and bone marrow reserve performed within 14 days prior to leukapheresis
- •Inclusion Criteria - Part 2:
- •Patients must not have been treated with immune check-point inhibitors
排除标准
- •All Patients:
- •Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to leukapheresis.
- •Systemic treatment with either corticosteroids (>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to leukapheresis
- •Patients treated with non-corticosteroid based immunosuppressive agents within the last 6 months prior to leukapheresis
- •Patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the Sponsor
- •Patients with >Grade 1 AEs related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to leukapheresis, except Grade 2 neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement
- •Known HIV infection, active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
- •Has known active central nervous system metastases
- •Have active interstitial lung disease and any history of myocarditis
- •Major surgery within 2 weeks of leukapheresis
- •Exclusion Criteria - Part 1B:
- •Known hypersensitivity to pembrolizumab
- •History of any Grade 3 immune-related AE (irAE) from prior immunotherapy
- •Exclusion Criteria - Part 2:
- •Prior treatment with an immune check-point inhibitor
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0
时间窗: Through 6 weeks after the patient's last dose of investigational product
For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Number of participants with dose-limiting toxicity (DLT)
时间窗: Through Day 42
For SQZ-eAPC-HPV in combination with pembrolizumab (Part 1B).
次要结局
- Objective response rate (ORR)(Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product)
- Best overall response (BoR)(Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product)
- Progression-free survival (PFS)(Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product)
- Duration of Response (DoR)(Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product)
- Disease-control rate (DCR)(Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product)
- Overall survival (OS)(Through study completion, up to 2 years)
- Amount of investigational product (IP) from individual patient blood collection - batch yield(From leukapheresis through manufacture, a maximum of 28 days)
- Amount of investigational product (IP) from individual patient blood collection - product failures(From leukapheresis through manufacture, a maximum of 28 days)
研究者
研究点 (18)
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