AST-021p Study in Advanced Solid Tumors

Advanced Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04864418
• Other study ID #: PN-021-11
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 9, 2021
• Est. completion date: November 2023

Study information

• Verified date: February 2023
• Source: Aston Sci. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: November 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• AST-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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul ST. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Aston Sci. Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immunogenicity assessment	ASP-021p specific IFN-? ELISpot(Interferon Gamma Enzyme-linked immunospot) test results and ASP-021p4 & ASP-021p5 specific IFN-? 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)
Secondary	Tumor response assessment	Disease control rate (%), objective response rate(%) and duration of response (days & weeks)	Overall study period approximately up to 5months
Secondary	Progression-Free Survival rate	PFS rate (%) at End of Study	Overall study period approximately up to 5months
Secondary	Overall Survival rate	OS rate (%) at End of study	Overall study period approximately up to 5months