AST-021p Study in Advanced Solid Tumors | NCT04864418 | Trialant

AST-021p Study in Advanced Solid Tumors | NCT04864418 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort group of AST-021p for dose-escalation	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AST-021p	Drug	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

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Contacts/Locations Module