A Phase 1 Study to Evaluate the Safety, Tolerability and Optimal Immunogenic Dose of Therapeutic Cancer Vaccine (AST-021p) in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Number of participants with treatment-related adverse events as assessed by AST-021p
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and optimal Immunogenic dose of therapeutic cancer vaccine (AST-021p) in patients With advanced solid tumors
A phase 1 study
详细描述
Recurrent or advanced solid cancer patients without applicable standard treatments will be included in the 4 dose groups (4 cohort groups- 1.2mg, 2.4mg, 3.6mg and 4.8mg) of AST-021p. Participants in each cohort group will be treated 3 times in each dose (3 priming immunications)
This study will apply a modified 3+3 design for dose-escalation.
1 participant will be registered in the lowest dose cohort group(1.2mg) and when the safety and tolerance of the AST-021p(1.2mg) are identified in the the first group, dose will be increased sequentially and accordingly, the safety and tolerance will be assessed for six participants in the other cohort groups (group2(2.4mg), group3(3.6mg) and group4(4.8mg)).
For subjects who received only priming immunization, safety and immunogenicity are assessed at the End of Treatment (EOT) visit. For subjects who received boosting immunization, safety and immunogenicity are assessed at the first booster dose (V6) and the End of Study (EOS) visit respectively.
Survival follow-up will be conducted every 3 months until the EOS visit of the last subject in the 4.8mg dose group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has recurrent or metastatic solid cancer that has been proven histologically or cytologically and cannot be treated with surgery or radiotherapy for the purpos of complete remission
- •does not have a standard treatment that can be applied clinically according to the investigator's judgment
- •has an expected life expectancy of more than 3 months
- •adults aged 19 or older based on screening day
- •ECOG performance status : 0~1
排除标准
- •Has a history of hypersensitivity or other contraindications to rhGM-CSF and Montanide ISA 51 VG
- •Has a history of other primary malignant tumor
- •Has autoimmune diseases or inflammatory diseases
- •Has a history of active primary immunodeficiency disease
- •Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
- •Is pregnant or breastfeeding or expecting to conceive children
- •has a history of immune suppression therapy ≤4 weeks prior to the screening day
研究组 & 干预措施
Cohort group of AST-021p for dose-escalation
4 cohort groups for AST- 021p administration:
Group 1) 1.2mg AST-021p, Montanide ISA 51 VG and rhuGM-CSF
Group 2) 2.4mg AST-021p, Montanide ISA 51 VG and rhuGM-CSF
Group 3) 3.6mg AST-021p, Montanide ISA 51 VG and rhuGM-CSF
Group 4) 4.8mg AST- 021p, Montanide ISA 51 VG and rhuGM-CSF
干预措施: AST-021p (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by AST-021p
时间窗: 6weeks after AST-021p administration in each cohort group
After AST-021p administration in patients with advance solid tumor, safety and tolerance are assessed for each dose group(1.2mg,2.4mg, 3.6mg \&4.8mg) Safety and tolerance evaluation variables : 1)adverse events 2) Vital signs 3)Physical examination 4) ECOG performance evaluation 5)ECG examination 6)Laboratory examination
Number of participants with treatment-related adverse events as assessed by AST-021p
时间窗: 6weeks and 20weeks after AST-021p administration in each cohort group
After AST-021p administration in patients with advance solid tumor, safety and tolerance are assessed for each dose group(1.2mg,2.4mg, 3.6mg \&4.8mg) Safety and tolerance evaluation variables : 1)adverse events 2) Vital signs 3)Physical examination 4) ECOG performance evaluation 5)ECG examination 6)Laboratory examination
次要结局
- Tumor response assessment(Overall study period approximately up to 5months)
- Immunogenicity assessment(8weeks after ASP-021p administration (Priming immunization case) or 20weeks after ASP-021p(Priming immunization and Boosting immunization case))
- Progression-Free Survival rate(Overall study period approximately up to 5months)
- Overall Survival rate(Overall study period approximately up to 5months)
- Immunogenicity assessment(8weeks after ASP-021p administration and 20weeks after ASP-021p administration)