Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.
NCT ID: NCT06344715
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
78 participants
INTERVENTIONAL
2022-10-17
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort S1
SL-T10 (3mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM)
SL-T10
A therapeutic DNA vaccine containing three prostate cancer-specific antigen genes and genetic adjuvants
GX-I7
A T-cell growth factor
Cohort S2
SL-T10 (6mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM)
SL-T10
A therapeutic DNA vaccine containing three prostate cancer-specific antigen genes and genetic adjuvants
GX-I7
A T-cell growth factor
Cohort a'
SL-T10 (3mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM), Pembrolizumab
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
Cohort A
SL-T10 (6mg, multiple injections, IM), GX-I7 (320 ug 2 injections, IM), Pembrolizumab
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
Cohort B
SL-T10 (6mg, multiple injections, IM) GX-I7 (720 ug 2 injections, IM) Pembrolizumab
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
Cohort C
SL-T10 (6mg, multiple injections, IM), GX-I7 (960 ug 2 injections, IM), Pembrolizumab
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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)
19 Years
MALE
No
Sponsors
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SL VAXiGEN
INDUSTRY
Responsible Party
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Principal Investigators
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Cheol Kwak, MD, phD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Chang Wook Jeong, MD, phD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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SL-T10-001_P1
Identifier Type: -
Identifier Source: org_study_id
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