Clinical trial NCT04864418: AST-021p Study in Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: cancer vaccine
Lead sponsor: Aston Sci. Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-28
Enrollment: 19
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by AST-021p
timeFrame: 6weeks after AST-021p administration in each cohort group
Secondary outcomes:
measure: Immunogenicity assessment
timeFrame: 8weeks after ASP-021p administration (Priming immunization case) or 20weeks after ASP-021p(Priming immunization and Boosting immunization case)
measure: Tumor response assessment
timeFrame: Overall study period approximately up to 5months
measure: Progression-Free Survival rate
timeFrame: Overall study period approximately up to 5months
measure: Overall Survival rate
timeFrame: Overall study period approximately up to 5months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul ST. Mary's Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Kyong Hwa Park, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: