AST-021p Study in Advanced Solid Tumors

Phase 1

Active, not recruiting

• Conditions: Advanced Cancer
• Interventions: Drug: AST-021p

• Registration Number: NCT04864418
• Lead Sponsor: Aston Sci. Inc.

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).

Study Timeline

• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-28
• Study Start: 2021-06-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20
• Primary Completion: 2023-08
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort group of AST-021p for dose-escalation	AST-021p	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

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by AST-021p	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 Outcome Measures

Name	Time	Method
Progression-Free Survival rate	Overall study period approximately up to 5months	PFS rate (%) at End of Study
Overall Survival rate	Overall study period approximately up to 5months	OS rate (%) at End of study
Tumor response assessment	Overall study period approximately up to 5months	Disease control rate (%), objective response rate(%) and duration of response (days \& weeks)
Immunogenicity assessment	8weeks after ASP-021p administration (Priming immunization case) or 20weeks after ASP-021p(Priming immunization and Boosting immunization case)	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)

Trial Locations

Locations (3)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of