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Trial Title:
Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.
NCT ID:
NCT06344715
Condition:
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Conditions: Official terms:
Prostatic Neoplasms
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
SL-T10
Description:
A therapeutic DNA vaccine containing three prostate cancer-specific antigen genes and
genetic adjuvants
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort S1
Arm group label:
Cohort S2
Arm group label:
Cohort a'
Intervention type:
Biological
Intervention name:
GX-I7
Description:
A T-cell growth factor
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort S1
Arm group label:
Cohort S2
Arm group label:
Cohort a'
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
An immune check point inhibitor
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort a'
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).
Detailed 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).
Criteria for eligibility:
Criteria:
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)
Gender:
Male
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Start date:
October 17, 2022
Completion date:
October 31, 2024
Lead sponsor:
Agency:
SL VAXiGEN
Agency class:
Industry
Source:
SL VAXiGEN
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06344715
