Advanced Cancer
Conditions
Keywords
cancer vaccine
Brief summary
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
Detailed description
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.
Interventions
DRUGAST-021p
3 priming immunization (2weeks x3) in 4 cohort groups (1.2mg, 2.4mg, 3.6mg and 4.8mg AST-021p) if possible, 3 boosting immunization (4weeks x 3) in cohort groups after priming immunization
Sponsors
Aston Sci. Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by AST-021p | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity assessment | 8weeks after ASP-021p administration and 20weeks after ASP-021p administration | AST-021p specific IFN-γ ELISpot(Interferon Gamma Enzyme-linked immunospot) test results and ASP-021p4 \& ASP-021p5 specific IFN-γ ELISpot |
| Tumor response assessment | Overall study period approximately up to 5months | Disease control rate (%), objective response rate(%) and duration of response (days \& weeks) |
| Progression-Free Survival rate | Overall study period approximately up to 5months | PFS rate (%) at 20weeks from first IP administration |
| Overall Survival rate | Overall study period approximately up to 5months | OS rate (%) at 20weeks from first IP administration |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORKyong Hwa Park, MD. PhD
Korea University Anam Hospital
Outcome results
None listed