In patients with advanced solid tumours, is an autologous cancer vaccine (RGSH4K), safe and tolerable, and can a biologically active dose be identified?
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Regeneus Ltd
- 入组人数
- 13
研究概览
简要总结
The single centre, open label, first-in-human Phase 1 study was designed to evaluate the safety and tolerability of RGSH4K and to identify the biologically active dose(s) to take into future trials. In this study,12 patients, heavily pretreated with chemotherapy or radiotherapy, with various advanced solid tumours received RGSH4K in 3 dose cohorts. A total of 3 vaccines were administered in the treatment phase, given at 3-week intervals, and patients had the option to continue dosing in an extension phase. All dose levels were safe and well tolerated, achieving the safety primary endpoint. There were no dose limiting toxicities and no serious adverse events related to the vaccine. Injection site reactions were the most common adverse event related to RGSH4K administration. RGSH4K also showed encouraging signs of immune stimulation in some patients, as demonstrated by changes in cancer markers, immune cells and cytokines. This immune stimulation was seen in one or more patients at all three dose levels. Preliminary indications of anti-tumour activity were seen in some patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •- aged 18 years or over
- •- has banked approximately 1 gram of fresh frozen tumour in the Regeneus tumour bank
- •- have advanced solid tumours which are inoperable or refractory to treatment, or chemoradiotherapy is contraindicated, or where standard treatments have failed or do not exist, or in a palliative setting where the patient has refused chemotherapy or it is contraindicated.
排除标准
- •- Rapidly progressing malignancy
- •- History of organ transplant and/or current immunosuppressive therapy, current systemic corticosteroids
- •- concurrent anticancer therapy, or within 4 weeks of vaccine
- •- Autoimmune disease
- •- known positive HIV or tests positive to HIV