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
Overview
- Phase
- Phase 1
- Intervention
- AST-021p
- Conditions
- Advanced Cancer
- Sponsor
- Aston Sci. Inc.
- Enrollment
- 19
- Locations
- 3
- Primary Endpoint
- Number of participants with treatment-related adverse events as assessed by AST-021p
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
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).
Investigators
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
Arms & Interventions
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
Intervention: AST-021p
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse events as assessed by AST-021p
Time Frame: 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
Secondary Outcomes
- Overall Survival rate(Overall study period approximately up to 5months)
- Progression-Free Survival rate(Overall study period approximately up to 5months)
- 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))