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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06344715
Other study ID # SL-T10-001_P1
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 17, 2022
Est. completion date October 31, 2024

Study information

Verified date March 2024
Source SL VAXiGEN
Contact Yong Bok Seo, phD
Phone 82-2-6098-2816
Email clinical@slvaxigen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC).


Description:

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SL-T10, GX-I7, and pembrolizumab in combination in patients with metastatic castration-resistant prostate cancer (mCRPC).


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender Male
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Male patients 19 years of age or older at the date of written informed consent. 2. Patients with histopathologically or cytologically confirmed adenocarcinoma of the prostate, documented by bone or soft tissue lesions. 3. Patients with castration-resistant prostate cancer with a blood testosterone level of less than 50 ng/dL at the screening visit. 4. patients with metastatic castration-resistant prostate cancer (mCRPC) who meet the following criteria (based on PCWG3.0 modified RECIST 1.1) 1) Prior taxane therapy for metastatic prostate cancer or confirmed refusal or inadequacy of such therapy 2) Patients who have received prior docetaxel and at least one of the following agents: abiraterone acetate or enzalutamide before or after docetaxel treatment 3) Patients with progression of prostate cancer during/after prior therapy, in the investigator's judgment, with either of the following, in the internal or external castration state 1. PSA progression defined as at least 2 PSA level increases (=1 week interval between each test) and a PSA level of =2 ng/mL at Screening 2. Advanced soft tissue disease as defined by RECIST 1.1 3. Progressive bone disease defined as =2 new lesions on bone scan (per PCWG3) 5. Patients who are on androgen deprivation therapy (ADT) of any kind (patients who have not undergone bilateral orchiectomy must begin internal castration therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or anti-androgenic agents, at least 4 weeks prior to Baseline and must continue for the entire duration of the study) Exclusion Criteria: 1. patient has an active autoimmune disease or is receiving systemic steroid therapy or in immunosuppressive status. 2. Patient has history of chemotherapy, radiation chemotherapy, biological therapy, immunotherapy, or radiation therapy within 4 weeks prior to the screening visit (In case of nitrosoureas or mitomycin, 6 weeks prior to the screening visit)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
SL-T10
A therapeutic DNA vaccine containing three prostate cancer-specific antigen genes and genetic adjuvants
GX-I7
A T-cell growth factor
Pembrolizumab
An immune check point inhibitor

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
SL VAXiGEN

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-emergent adverse events (TEAEs) Number of participants with treatment-emergent adverse events (TEAEs) Baseline to 23 weeks
Primary Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 Baseline to 48 weeks
Secondary PSA response rate % patients with a reduction in PSA level from baseline by 50% or greater Baseline to 48 weeks
Secondary PSA progression free survival The interval from the date of randomisation to the date of first evidence of PSA progression or death from any cause, whichever occurred first. Baseline to 48 weeks
Secondary Radiographic progression free survival The interval from the date of disease progression on CT and/or Tc bone scan or death from any cause, whichever occurred first. Baseline to 48 weeks
Secondary Change of induced T-cell responses for SL-T10 vaccine Vaccine-induced T-cell responses assessed by immunoassays in peripheral blood Baseline to 48 weeks
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