drugset / Trial / NCT01967758
Phase I Study of Safety and Immunogenicity of ADU-623
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a study for patients with brain tumors called astrocytic tumors. The study will enroll patients who have received standard treatment. The study will test a vaccine called ADU-623. ADU-623 has not been tested in humans before, so the goal of this study is to see if ADU-623 can be given safely to brain cancer patients and what is the better dose to give patients among the three doses that planned to be tested. This study will also evaluate the length of time before patients' cancer worsens and if ADU-623 helps patients to live longer. The study will also measure the body's immune system response to ADU-623.
Timeline
- Start
- 2014-01-08
- Primary completion
- 2018-06-18
- Completion
- 2018-08-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADU-623 | Vaccine | 3e+07 unknown | Intravenous |
| Subject | ADU-623 | Vaccine | 3e+08 unknown | Intravenous |
| Subject | ADU-623 | Vaccine | 3e+09 unknown | Intravenous |
| Background | Amoxicillin | Other / unclassified | 500 mg | Oral |
| Background | Sulfamethoxazole | Small molecule | 800 mg | Oral |
| Background | Trimethoprim | Small molecule | 160 mg | Oral |