AST-021p Study in Advanced Solid Tumors

Study Overview
=================
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)). Participants receiving priming immunization only will be assessed up to End of Treatment(EOT) and participants who recive boosting immunization will be evaluated until the end of study(EOS).

Official Title
-----------------
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

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Drug: AST-021p


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort group of AST-021p for dose-escalation<br>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 | Drug: AST-021p<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by AST-021p | 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 | 6weeks after AST-021p administration in each cohort group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity assessment | ASP-021p specific IFN-γ ELISpot(Interferon Gamma Enzyme-linked immunospot) test results and ASP-021p4 & ASP-021p5 specific IFN-γ ELISpot ( spots/250,000 Tcell of pre ASP-021p and post ASP-021p) | 8weeks after ASP-021p administration (Priming immunization case) or 20weeks after ASP-021p(Priming immunization and Boosting immunization case) | 
| Tumor response assessment | Disease control rate (%), objective response rate(%) and duration of response (days & weeks) | Overall study period approximately up to 5months | 
| Progression-Free Survival rate | PFS rate (%) at End of Study | Overall study period approximately up to 5months | 
| Overall Survival rate | OS rate (%) at End of study | Overall study period approximately up to 5months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer vaccine