NCT07687875招募中1 期
A Phase I Study of the Safety and Efficacy of a Modified Vaccinia Virus (BT-001) Delivered by Endoscopic Intra-tumoural Injection Followed by Systemic Antiprogammed Death-1 (Anti-PD-1) Antibodies in Patients With Localised Rectal Cancer With Proficient Mismatch Repair (pMMR)
Henry Smith1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年6月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall incidence of adverse events (AEs)
研究概览
简要总结
A Phase I clinical trial that will investigate the safety and tolerability of combining the modified vaccinia virus BT-001 with systemic pembrolizumab in patients with localised pMMR rectal cancer
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
- •Histological diagnosis of primary, localised rectal adenocarcinoma (cT2N0M0 to cT3bN2M0, TNM classification version 8
- •Diagnosis of Proficient Mismatch Repair (pMMR) rectal adenocarcinoma (using biopsy from the initial diagnostic endoscopy)
- •Suitable for potentially curative surgical resection
- •No contraindications for treatment with pembrolizumab
- •Not requiring neoadjuvant therapy
- •Aged > 18 years at the time of inclusion
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Have baseline laboratory results as follows:
- •Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
- •Platelets ≥ 100 ×109/L (without platelet transfusion)
- •Haemoglobin ≥ 6.2 mmol/L or 10.0 g/dL (with or without red blood cell (RBC) transfusion)
- •Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
- •Bilirubin < 1.5 × ULN (or < 2.5 x ULN in patients with Gilbert's syndrome)
- •ALT, AST and alkaline phosphatase < 3 × ULN
- •Provide written informed consent in accordance with all applicable regulations and follow the study procedures. Subjects must be capable of understanding the investigational nature, potential risks, and benefits of the study.
排除标准
- •Have impending bowel obstruction or other indications for acute surgical intervention
- •Have had concurrent immunotherapy in the 3 months before the start of the study therapy.
- •Have acute or chronic hepatitis B or hepatitis C infection
- •Evidence of immunosuppression for any reason:
- •Known HIV disease
- •Chronic oral or systemic steroid medication use at a dose of > 10 mg/day of prednisolone or equivalent
- •Other signs or symptoms of clinical immune system suppression
- •Have an autoimmune disorder (except thyroiditis with replacement therapy and type I diabetes mellitus)
- •Have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- •Ongoing antiviral therapy active on vaccinia virus, e.g., ribavirin, cidofovir, interferon/ pegylated interferon
- •History of severe exfoliative skin conditions (e.g., eczema or atopic dermatitis) requiring systemic therapy for more than 4 weeks within 2 years prior to BT-001 initiation
- •Live virus vaccination within 28 days of BT-001 administration
- •A history of hypersensitivity to egg or to any excipient of BT-001
- •Pregnant or breast-feeding female. Confirmation that women of childbearing potential are not pregnant with a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test results must be obtained within 7 days prior to the 1st administration of BT-001
- •Fertile males and females who are unwilling to employ highly effective means of contraception during study treatment and for 4 months after the last dose of study treatment
研究组 & 干预措施
Treatment with BT-001 and pembrolizumab
Experimental
Two doses of BT-001 delivered by intra-tumoural injection followed by one systemic dose of pembrolizumab
干预措施: BT-001 followed by Pembrolizumab (PD-1 Blocking Antibody) (Drug)
结局指标
主要结局
Overall incidence of adverse events (AEs)
时间窗: Within 30 days of the end of the study treatment
Evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Overall incidence of serious adverse events (SAEs)
时间窗: Within 30 days of the end of the study treatment
Evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Overall incidence of dose limiting toxicities (DLTs)
时间窗: Within 30 days of the end of the study treatment
Incidence of dose-limiting toxicities
次要结局
- Effects of the study treatment on long-term oncological outcomes(Up to 5 years after the end of the study treatment)
- Clinical efficacy of BT-001 when delivered by endoscopic/transrectal ultrasound guided intra-tumoural injection in combination with a single systemic dose of pembrolizumab in patients with primary, localised, rectal cancer with proficient mismatch repair(Within 6 weeks of the start of the study treatment)
- Determine the effects of the study treatment on patient's quality of life(Up to 5 years after the end of the study treatment)
研究者
Henry Smith
Associate Professor
Bispebjerg Hospital
研究点 (1)
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