A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants With Select Epithelial Solid Tumours Under Multiple Sub-protocols
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 11
- 主要终点
- • Incidence of treatment emergent adverse events (AEs) [safety and tolerability]
研究概览
简要总结
ATTR-01 is the experimental drug being studied in the ATTEST clinical trial. The drug is made from a common cold virus that has been changed to only infect and multiply in cancer cells. This virus delivers an immune therapy drug into the cancer that is intended to promote a participant's own immune system to attack the cancer. The first part of this trial (sub-protocol A) is a phase 1 trial including dose escalation and expansion at one or more doses. It is the first time that ATTR-01 will be given to humans. If an optimal dose is identified, additional sub-protocols will be added by to further elicit whether ATTR-01 may successfully treat cancer. Expanded access is not available.
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
- •Consenting male and female adults (18 years of age) with select solid epithelial tumour indications known to have high frequency (75 percent) of αvβ6 integrin receptor expression as detailed in the applicable SP.
- •Received and failed/intolerant of Standard of Care (SoC) therapy where eligible (not including neoadjuvant).
- •Tumour lesion (not previously irradiated), suitable for safe pre- and post-treatment biopsies.
- •Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or
- •Minimum life expectancy anticipated to be greater than three months
- •Willing to undertake appropriate measures of hygiene to prevent any spread of virus and protection of vulnerable individuals.
- •Adequate organ function.
- •Compliant with requirements for prior treatment washout and contraceptive measures applicable to genetically modified organisms (GMOs) and cancer therapies
- •Prior immune checkpoint antibody therapies as single agents or in combination with other anti-cancer agents is permissible.
排除标准
- •Significant degree of fibrotic disease, including autoimmune diseases (e.g. systemic lupus, rheumatoid arthritis) or idiopathic and occupation-related pulmonary fibrosis.
- •Known prior history of intolerance to anti-programmed cell death protein 1 (PD-1) and/or anti-PD-L1 immunotherapy due to toxicity.
- •Has any of the comorbid conditions listed in the detailed protocol exclusion criteria.
研究组 & 干预措施
Single group
干预措施: ATTR-01 (Drug)
结局指标
主要结局
• Incidence of treatment emergent adverse events (AEs) [safety and tolerability]
时间窗: 1 year, 2 years and 5 years
• Determination of the optimal dose of ATTR-01
时间窗: 1 year, 2 years and 5 years
• Incidence of AEs, serious adverse events (SAEs), dose limiting toxicities (DLTs), discontinuation of investigational product(s) due to toxicity and clinically significant alterations in vital signs or other clinical safety assessments
• Objective Response Rate (ORR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
时间窗: 1 year, 2 years and 5 years
Duration of Response (DoR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
时间窗: 1 year, 2 years and 5 years
次要结局
- Disease Control Rate (DCR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1](1 year, 2 years and 5 years)
- Time To Response (TTR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1](1 year, 2 years and 5 years)
- Progression Free Survival (PFS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1](1 year, 2 years and 5 years)
- Overall Survival (OS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1](1 year, 2 years and 5 years)
- Maximum reduction in tumour size [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1](1 year, 2 years and 5 years)
- Duration of Response (DoR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1](1 year, 2 years and 5 years)
- To evaluate the viral persistence of ATTR-01(1 year)
- To evaluate the immunogenicity of ATTR-01(1 year)