Last updated: March 27, 2024
Sponsor: SL VAXiGEN
Overall Status: Active - Recruiting
Phase
1
Condition
Prostate Disorders
Prostate Cancer
Urologic Cancer
Treatment
Pembrolizumab
SL-T10
GX-I7
Clinical Study ID
NCT06344715
SL-T10-001_P1
Ages > 19 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male patients 19 years of age or older at the date of written informed consent.
- Patients with histopathologically or cytologically confirmed adenocarcinoma of theprostate, documented by bone or soft tissue lesions.
- Patients with castration-resistant prostate cancer with a blood testosterone level ofless than 50 ng/dL at the screening visit.
- patients with metastatic castration-resistant prostate cancer (mCRPC) who meet thefollowing criteria (based on PCWG3.0 modified RECIST 1.1)
- Prior taxane therapy for metastatic prostate cancer or confirmed refusal or inadequacyof such therapy 2) Patients who have received prior docetaxel and at least one of thefollowing agents: abiraterone acetate or enzalutamide before or after docetaxel treatment
- Patients with progression of prostate cancer during/after prior therapy, in theinvestigator's judgment, with either of the following, in the internal or externalcastration state
- PSA progression defined as at least 2 PSA level increases (≥1 week interval betweeneach test) and a PSA level of ≥2 ng/mL at Screening
- Advanced soft tissue disease as defined by RECIST 1.1
- Progressive bone disease defined as ≥2 new lesions on bone scan (per PCWG3)
- Patients who are on androgen deprivation therapy (ADT) of any kind (patients who havenot undergone bilateral orchiectomy must begin internal castration therapy, such asluteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or anti-androgenicagents, at least 4 weeks prior to Baseline and must continue for the entire duration of thestudy)
Exclusion
Exclusion Criteria:
- patient has an active autoimmune disease or is receiving systemic steroid therapy orin immunosuppressive status.
- Patient has history of chemotherapy, radiation chemotherapy, biological therapy,immunotherapy, or radiation therapy within 4 weeks prior to the screening visit (Incase of nitrosoureas or mitomycin, 6 weeks prior to the screening visit)
Study Design
Total Participants: 78
Treatment Group(s): 3
Primary Treatment: Pembrolizumab
Phase: 1
Study Start date:
October 17, 2022
Estimated Completion Date:
October 31, 2024
Study Description
Connect with a study center
Seoul National University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
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